Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00187278
Collaborator
(none)
1,833
1
2
137
13.4
Study Details
Study Description
Brief Summary
The primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS duration will profit from the prevention of ventricular desynchronisation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study will be performed as a controlled, single-blind, international, multicenter, prospective, randomized, parallel group design.
In order to pragmatically examine the effectiveness of biventricular pacing in patients with an indication for ventricular pacing, the study group with biventricular pacing is compared to a control group with standard pacemakers which only allow univentricular (right ventricular) stimulation, as it has been the standard outside of clinical studies until so far.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1833 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization
Study Start Date
:
May 1, 2003
Actual Primary Completion Date
:
May 1, 2014
Actual Study Completion Date
:
Oct 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: RV Pacing Standard Pacemaker implant |
Device: RV Pacing
Standard Pacemaker implant
|
| Experimental: Biventricular Pacing Biventricular Pacemaker implant |
Device: Biventricular Pacing
Biventricular Pacemaker implant
|
Outcome Measures
Primary Outcome Measures
- Total Mortality [Study duration (5.7 years mean follow-up)]
Number of deaths observed
- Death or Heart Failure Hospitalization [Study duration (5.7 years mean follow-up)]
Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization
Secondary Outcome Measures
- Death Due to Cardiovascular Causes [Study duration (5.7 years mean follow-up)]
Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC)
- Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test [12 months post-implant]
- Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© [12 months post-implant]
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
- Incidence of Hospitalizations for Deterioration of Heart Failure [Study duration (5.7 years mean follow-up)]
- Incidence of Hospitalizations for Cardiovascular Events [Study duration (5.7 years mean follow-up)]
- Incidence of Hospitalizations for Any Reason [Study duration (5.7 years mean follow-up)]
- Cardiac Structure and Function [12 & 24 months]
- Successful Implantation of the Left Ventricular Lead [Implantation]
- Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits) [Study duration (5.7 years mean follow-up)]
Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits.
- Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test [24 months post-implant]
- Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© [24 months post-implant]
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months. MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
- Duration of Hospitalizations for Deterioration of Heart Failure [Study Duration (5.7 years mean follow-up)]
- Duration of Hospitalizations for Cardiovascular Events [Study Duration (5.7 years mean follow-up)]
- Duration of Hospitalizations for Any Reason [Study duration (5.7 years mean follow-up)]
- Adverse Events Related to Left Ventricular Lead [Study Duration (5.7 years mean follow-up)]
Only serious adverse events related to the left ventricular lead are included.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Presence of an indication for ventricular pacing according to the actual guidelines for the implantation of cardiac pacemakers and a need for frequent (or even permanent) ventricular pacing for:
-
Permanent 3rd degree atrioventricular (AV)-block or
-
Intermittent 3rd degree AV-block in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
-
2nd degree AV-block type Mobitz II in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
-
2nd degree AV-block type Mobitz I (if indicated) in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
-
1st degree AV-block with a pQ-interval ≥ 220 ms and indication for ventricular pacing (includes indication for ventricular pacing based on long HV interval measured during invasive electrophysiological testing) or
-
Sick-sinus-syndrome with symptomatic sinus bradycardia or sinus arrest as primary indication for device implantation in combination with long 1st degree AV-block with a pQ-interval ≥ 220 ms or
-
Chronic (permanent) atrial fibrillation (flutter or tachycardia) with a spontaneous heart (ventricular) rate at rest ≤ 60/min or
-
Chronic (permanent) atrial fibrillation (flutter or tachycardia) with a spontaneous heart (ventricular) rate at rest ≤ 75/min, if initiation or increase of pharmacological treatment with a relevant heart rate lowering effect (negative chronotropic effect) is planned for the time after pacemaker implantation (i.e. ß-blockers for heart failure and rate control)
-
Patients scheduled for AV node ablation
-
Any QRS duration and morphology
-
Left ventricular ejection fraction (LVEF) without limit as measured by echocardiography (in at least one plane, either 4- or 2-chamber or apical long axis view)
-
Signed written informed consent of the patient or a first-degree relative for study participation after informing the patient/relative about the risks and the aim of the study
-
Willingness and ability to comply with the prescribed follow-up tests and schedule of evaluations.
-
Absence of an implanted ventricular pacing device (patients with atrial pacemakers and new need for ventricular pacing may be included)
Exclusion Criteria:
-
Implanted Cardioverter Defibrillator or consideration for implantation of an ICD due to arrhythmia indication. However, ICD implant for primary prevention of sudden cardiac death in patients with LVEF ≤ 35 % (in accordance with the actual guidelines for the implantation of arrhythmia devices[LVEF < 30%] and in accordance with the results of the SCD-Heft study [LVEF < 35%) will be allowed.
-
Implanted ventricular pacing device
-
Status 1 for cardiac transplantation and likelihood to receive transplantation within 2 years (these patients would not be expected to fulfill the follow-up requirements as outlined in this protocol)
-
Evidence of acute left ventricular dysfunction and high probability for its reversibility (e.g. acute myocarditis, tachycardiomyopathy)
-
Implanted prosthetic tricuspid valve
-
Severe musculoskeletal disorder(s)
-
Age below 18 years
-
Current or planned pregnancy in the next 6 months
-
Current or recent (within the past 30 days) participation in any other clinical investigation
-
Life expectancy of less than 6 months
-
Patient's inability to independently comprehend and complete the Quality of Life (QoL) questionnaire
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum der Philipps-Universität Marburg | Marburg | Germany | 35033 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Reinhard Funck, MD, Klinikum Bad Hersfeld, Germany
- Study Chair: Jean-Jacques Blanc, Prof., Hôpital Cavale Blanche, Brest, France
Study Documents (Full-Text)
None provided.More Information
Publications
- Funck RC, Blanc JJ, Mueller HH, Schade-Brittinger C, Bailleul C, Maisch B; BioPace Study Group. Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the 'Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)' study. Europace. 2006 Aug;8(8):629-35.
- Funck RC, Mueller HH, Lunati M, Piorkowski C, De Roy L, Paul V, Wittenberg M, Wuensch D, Blanc JJ; BioPace study group. Characteristics of a large sample of candidates for permanent ventricular pacing included in the Biventricular Pacing for Atrio-ventricular Block to Prevent Cardiac Desynchronization Study (BioPace). Europace. 2014 Mar;16(3):354-62. doi: 10.1093/europace/eut343. Epub 2013 Nov 7.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT00187278
Other Study ID Numbers:
- CR03006HF
First Posted:
Sep 16, 2005
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients were enrolled between May 2003 and September 2007. |
|---|---|
| Pre-assignment Detail | 1834 patients have been scheduled for randomization, while 1833 have been randomized to RV Pacing or Biventricular group. One patient could not be randomized due to organizational reasons. |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Period Title: Overall Study | ||
| STARTED | 918 | 915 |
| COMPLETED | 908 | 902 |
| NOT COMPLETED | 10 | 13 |
Baseline Characteristics
| Arm/Group Title | RV Pacing | Biventricular Pacing | Total |
|---|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant | Total of all reporting groups |
| Overall Participants | 908 | 902 | 1810 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
73.3
(9.0)
|
73.8
(9.0)
|
73.5
(9.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
296
32.6%
|
278
30.8%
|
574
31.7%
|
| Male |
612
67.4%
|
624
69.2%
|
1236
68.3%
|
| Body mass index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
27.5
(4.7)
|
27.4
(4.3)
|
27.4
(4.5)
|
| Ventricular pacing at 1 month (%) [Mean (Inter-Quartile Range) ] | |||
| Mean (Inter-Quartile Range) [%] |
86.4
|
90.2
|
88.3
|
| Underlying cardiac diseases (participants) [Number] | |||
| All |
572
63%
|
571
63.3%
|
1143
63.1%
|
| Ischaemic heart disease |
274
30.2%
|
274
30.4%
|
548
30.3%
|
| Hypertensive heart disease |
281
30.9%
|
262
29%
|
543
30%
|
| Dlated cardiomyopathy |
43
4.7%
|
51
5.7%
|
94
5.2%
|
| Valvulopathy |
170
18.7%
|
165
18.3%
|
335
18.5%
|
| Prior MI |
162
17.8%
|
141
15.6%
|
308
17%
|
| Cardiovascular risk factor (participants) [Number] | |||
| Hypertension |
696
76.7%
|
666
73.8%
|
1362
75.2%
|
| Diabetes mellitus |
255
28.1%
|
251
27.8%
|
506
28%
|
| Left ventricular ejection fraction (LVEF) (%) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [%] |
55.5
(12.4)
|
55.3
(12.1)
|
55.4
(12.2)
|
| Left Ventricular Ejection Fraction (LVEF) range (participants) [Number] | |||
| LVEF ≤ 35% |
74
8.1%
|
78
8.6%
|
152
8.4%
|
| 35% < LVEF ≤ 50% |
221
24.3%
|
198
22%
|
419
23.1%
|
| LVEF > 50% |
613
67.5%
|
626
69.4%
|
1239
68.5%
|
| QRS duration (ms) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [ms] |
118.8
(30.3)
|
118.1
(30.8)
|
118.4
(30.5)
|
| QRS range (participants) [Number] | |||
| QRS ≤ 120ms |
571
62.9%
|
571
63.3%
|
1142
63.1%
|
| 120ms < QRS ≤ 150ms |
190
20.9%
|
176
19.5%
|
366
20.2%
|
| QRS > 150ms |
147
16.2%
|
155
17.2%
|
302
16.7%
|
| Atrial arrhythmias (participants) [Number] | |||
| Atrial arrhythmias |
225
24.8%
|
225
24.9%
|
450
24.9%
|
| None |
683
75.2%
|
677
75.1%
|
1360
75.1%
|
| Left bundle branch block (LBBB) (participants) [Number] | |||
| LBBB |
166
18.3%
|
150
16.6%
|
316
17.5%
|
| None |
742
81.7%
|
752
83.4%
|
1494
82.5%
|
| Scheduled for ICD (participants) [Number] | |||
| Scheduled for ICD |
22
2.4%
|
26
2.9%
|
48
2.7%
|
| Not scheduled for ICD |
886
97.6%
|
976
108.2%
|
1762
97.3%
|
| Indications for device implantation (participants) [Number] | |||
| Persistent bradycardia |
538
59.3%
|
540
59.9%
|
1078
59.6%
|
| Intermittent bradycardia |
368
40.5%
|
362
40.1%
|
730
40.3%
|
| Unknown |
2
0.2%
|
0
0%
|
2
0.1%
|
Outcome Measures
| Title | Total Mortality |
|---|---|
| Description | Number of deaths observed |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 908 | 902 |
| Count of Participants [Participants] |
307
33.8%
|
305
33.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | RV Pacing, Biventricular Pacing |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3492 |
| Comments | adjusted p | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.926 | |
| Confidence Interval |
(2-Sided) 95% 0.789 to 1.0088 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Death or Heart Failure Hospitalization |
|---|---|
| Description | Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 908 | 902 |
| Count of Participants [Participants] |
346
38.1%
|
363
40.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | RV Pacing, Biventricular Pacing |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0882 |
| Comments | adjusted p | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.878 | |
| Confidence Interval |
(2-Sided) 95% 0.756 to 1.020 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Death Due to Cardiovascular Causes |
|---|---|
| Description | Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC) |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 908 | 902 |
| Count of Participants [Participants] |
106
11.7%
|
107
11.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | RV Pacing, Biventricular Pacing |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8215 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.97 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test |
|---|---|
| Description | |
| Time Frame | 12 months post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis includes all enrolled patients who completed the 6-minute walk test both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 672 | 675 |
| Mean (Standard Deviation) [meters] |
371.3
(128.8)
|
371.2
(129.1)
|
| Title | Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© |
|---|---|
| Description | Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. |
| Time Frame | 12 months post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis includes all enrolled patients who completed the Minnesota Living With Heart Failure questionnaire both at the baseline and 12-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 724 | 715 |
| Mean (Standard Deviation) [score on a scale] |
16.0
(15.4)
|
15.3
(15.5)
|
| Title | Incidence of Hospitalizations for Deterioration of Heart Failure |
|---|---|
| Description | |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 899 | 888 |
| Number [hospitalization per patient year] |
0.043
|
0.037
|
| Title | Incidence of Hospitalizations for Cardiovascular Events |
|---|---|
| Description | |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 899 | 888 |
| Number [hospitalizations per patient year] |
0.162
|
0.161
|
| Title | Incidence of Hospitalizations for Any Reason |
|---|---|
| Description | |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 899 | 888 |
| Number [Hospitalization per patient year] |
0.392
|
0.432
|
| Title | Cardiac Structure and Function |
|---|---|
| Description | |
| Time Frame | 12 & 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data related to cardiac structure and function can not be presented as the data was not collected and analysis provided by the core lab. |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 0 | 0 |
| Title | Successful Implantation of the Left Ventricular Lead |
|---|---|
| Description | |
| Time Frame | Implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| There was an attempt of left ventricular lead implantation only for subjects from Biventricular Pacing group. |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 0 | 883 |
| Number [participants] |
760
83.7%
|
| Title | Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits) |
|---|---|
| Description | Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits. |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 908 | 902 |
| Number [participants] |
91
10%
|
76
8.4%
|
| Title | Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test |
|---|---|
| Description | |
| Time Frame | 24 months post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 614 | 592 |
| Mean (Standard Deviation) [meters] |
369.3
(127.2)
|
376.5
(132.0)
|
| Title | Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© |
|---|---|
| Description | Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months. MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status. |
| Time Frame | 24 months post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis includes all enrolled patients who completed the Minnesota Living With Heart Failure questionnaire both at the baseline and 24-month visits. Due to that reason, the overall number of participants analyzed is different from the participant module. |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 662 | 675 |
| Mean (Standard Deviation) [score on a scale] |
17.5
(17.6)
|
17.3
(16.6)
|
| Title | Duration of Hospitalizations for Deterioration of Heart Failure |
|---|---|
| Description | |
| Time Frame | Study Duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 899 | 888 |
| Number [days per patient year] |
0.40
|
0.39
|
| Title | Duration of Hospitalizations for Cardiovascular Events |
|---|---|
| Description | |
| Time Frame | Study Duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 899 | 888 |
| Number [Days per patient year] |
1.52
|
1.50
|
| Title | Duration of Hospitalizations for Any Reason |
|---|---|
| Description | |
| Time Frame | Study duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant RV Pacing: Standard Pacemaker implant | Biventricular Pacemaker implant Biventricular Pacing: Biventricular Pacemaker implant |
| Measure Participants | 899 | 888 |
| Number [days per patient year] |
3.72
|
4.14
|
| Title | Adverse Events Related to Left Ventricular Lead |
|---|---|
| Description | Only serious adverse events related to the left ventricular lead are included. |
| Time Frame | Study Duration (5.7 years mean follow-up) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | RV Pacing | Biventricular Pacing |
|---|---|---|
| Arm/Group Description | Standard Pacemaker implant | Biventricular Pacemaker implant |
| Measure Participants | 908 | 902 |
| Number [participants] |
1
0.1%
|
38
4.2%
|
Adverse Events
| Time Frame | Study duration (5.7 years mean follow-up) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The sponsor assessed all events except the death cases without further information, duplicate events and uncomplicated device replacement due to end of life. 5628 events were reviewed and assessed by the sponsor. Subjects may experience more than one adverse event. | |||
| Arm/Group Title | RV Pacing | Biventricular Pacing | ||
| Arm/Group Description | Standard Pacemaker implant | Biventricular Pacemaker implant | ||
All Cause Mortality |
||||
| RV Pacing | Biventricular Pacing | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 307/908 (33.8%) | 305/902 (33.8%) | ||
Serious Adverse Events |
||||
| RV Pacing | Biventricular Pacing | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 641/908 (70.6%) | 698/902 (77.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 14/908 (1.5%) | 19 | 14/902 (1.6%) | 16 |
| Epistaxis | 3/908 (0.3%) | 3 | 2/902 (0.2%) | 2 |
| Haemoptysis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Hematochezia | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Hypercalcemia | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Hyperkalemia | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Hyponatremia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Thromboemboli | 2/908 (0.2%) | 2 | 6/902 (0.7%) | 6 |
| Cardiac disorders | ||||
| AV Fistula | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 5 |
| Acute Coronary Syndrome | 5/908 (0.6%) | 7 | 1/902 (0.1%) | 1 |
| Angina | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Arrhythmia | 48/908 (5.3%) | 56 | 54/902 (6%) | 75 |
| Bradycardia | 3/908 (0.3%) | 3 | 0/902 (0%) | 0 |
| Cardiac arrest | 2/908 (0.2%) | 2 | 2/902 (0.2%) | 3 |
| Cardiomyopathy | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Chest Pain | 50/908 (5.5%) | 68 | 48/902 (5.3%) | 63 |
| Dyspnea | 46/908 (5.1%) | 71 | 60/902 (6.7%) | 74 |
| Endocarditis | 2/908 (0.2%) | 2 | 5/902 (0.6%) | 7 |
| Exacerbation of heart failure | 132/908 (14.5%) | 179 | 103/902 (11.4%) | 144 |
| Hypertension | 13/908 (1.4%) | 16 | 18/902 (2%) | 20 |
| Hypertrophic obstructive cardiomyopathy | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Hypotension | 5/908 (0.6%) | 5 | 5/902 (0.6%) | 5 |
| Mitral Regurgitation | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Myocardial infarction | 29/908 (3.2%) | 34 | 26/902 (2.9%) | 26 |
| Palpitations | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 3 |
| Rise in threshold and exit block | 12/908 (1.3%) | 12 | 22/902 (2.4%) | 24 |
| Shortness of Breath | 4/908 (0.4%) | 4 | 3/902 (0.3%) | 3 |
| Valve damage | 26/908 (2.9%) | 36 | 18/902 (2%) | 19 |
| Congenital, familial and genetic disorders | ||||
| Lowry Wood Syndrome | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Vertigo | 0/908 (0%) | 0 | 4/902 (0.4%) | 4 |
| Endocrine disorders | ||||
| Diabetes | 10/908 (1.1%) | 13 | 12/902 (1.3%) | 12 |
| Glycemia | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Hyperglycemia | 2/908 (0.2%) | 2 | 4/902 (0.4%) | 4 |
| Hypoglycemia | 3/908 (0.3%) | 5 | 5/902 (0.6%) | 6 |
| Eye disorders | ||||
| Cataract | 2/908 (0.2%) | 3 | 1/902 (0.1%) | 1 |
| Galucoma | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Macular Degeneration | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| Cholangitis | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Constipation | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| Diverticulitis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Gastrointestinal Bleeding | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Gastrointestinal disease | 0/908 (0%) | 0 | 3/902 (0.3%) | 3 |
| Gastrointestinal disorder | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Nausea | 3/908 (0.3%) | 3 | 2/902 (0.2%) | 2 |
| Pancreatitis | 4/908 (0.4%) | 6 | 3/902 (0.3%) | 4 |
| Ulcer | 2/908 (0.2%) | 2 | 4/902 (0.4%) | 6 |
| Antral gastritis | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Appendicitis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Bowel obstruction | 1/908 (0.1%) | 2 | 0/902 (0%) | 0 |
| Diarrhea | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 3 |
| Gastroenteritis | 4/908 (0.4%) | 4 | 2/902 (0.2%) | 2 |
| Hernia | 16/908 (1.8%) | 16 | 8/902 (0.9%) | 8 |
| Intestinal Obstruction | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Rectal Bleeding | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| General disorders | ||||
| Dizziness | 15/908 (1.7%) | 17 | 16/902 (1.8%) | 18 |
| Drug Toxicity | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Dysphagia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Dysphonia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Esophagitis | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Fever | 11/908 (1.2%) | 11 | 12/902 (1.3%) | 13 |
| Hospitalization for non-cardiac diseases | 74/908 (8.1%) | 86 | 87/902 (9.6%) | 110 |
| Hydrocephalus | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Influenza | 5/908 (0.6%) | 5 | 1/902 (0.1%) | 1 |
| Lyme Disease | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Malaise | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Pain | 47/908 (5.2%) | 57 | 55/902 (6.1%) | 65 |
| Shingles | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Stenosis | 22/908 (2.4%) | 22 | 17/902 (1.9%) | 20 |
| Syncope | 22/908 (2.4%) | 25 | 17/902 (1.9%) | 18 |
| Weakness | 6/908 (0.7%) | 6 | 4/902 (0.4%) | 5 |
| Worsening of General Patient's Condition | 39/908 (4.3%) | 47 | 59/902 (6.5%) | 65 |
| Hepatobiliary disorders | ||||
| Cirrhosis | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 3 |
| Gallbladder disease | 2/908 (0.2%) | 2 | 2/902 (0.2%) | 2 |
| Gallstones | 1/908 (0.1%) | 1 | 8/902 (0.9%) | 11 |
| Jaundice | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Immune system disorders | ||||
| Allergy | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Infections and infestations | ||||
| Infection | 58/908 (6.4%) | 76 | 87/902 (9.6%) | 118 |
| Sepsis | 6/908 (0.7%) | 6 | 7/902 (0.8%) | 10 |
| Septic shock | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Abdominal adhesions post surgery | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Accidental injury | 2/908 (0.2%) | 2 | 8/902 (0.9%) | 8 |
| Acute hemorrhage/bleeding | 26/908 (2.9%) | 27 | 35/902 (3.9%) | 39 |
| Air emboli | 9/908 (1%) | 11 | 10/902 (1.1%) | 10 |
| Amputation | 5/908 (0.6%) | 7 | 8/902 (0.9%) | 9 |
| Cardiac or venous perforation | 6/908 (0.7%) | 6 | 9/902 (1%) | 9 |
| Cardiac/coronary sinus dissection | 2/908 (0.2%) | 2 | 3/902 (0.3%) | 3 |
| Coronary sinus or cardiac vein thrombosis | 5/908 (0.6%) | 5 | 6/902 (0.7%) | 6 |
| Erosion | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Excessive bleeding | 6/908 (0.7%) | 6 | 2/902 (0.2%) | 2 |
| Extracardiac stimulation (phrenic nerve, diaphragm, chest wall) | 1/908 (0.1%) | 1 | 12/902 (1.3%) | 12 |
| Fall | 33/908 (3.6%) | 34 | 39/902 (4.3%) | 42 |
| Hematoma/seroma formation | 14/908 (1.5%) | 22 | 19/902 (2.1%) | 19 |
| Laceration | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Medication Error | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Pericardial effusion | 1/908 (0.1%) | 1 | 8/902 (0.9%) | 10 |
| Pericarditis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Pleural Effusion | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Pneumothorax | 3/908 (0.3%) | 3 | 5/902 (0.6%) | 5 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/908 (0.2%) | 2 | 3/902 (0.3%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 2/908 (0.2%) | 2 | 2/902 (0.2%) | 2 |
| Bone fracture | 24/908 (2.6%) | 28 | 32/902 (3.5%) | 37 |
| Coxarthrosis | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Gout | 2/908 (0.2%) | 2 | 1/902 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adenomatous polyps | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Cancer | 24/908 (2.6%) | 26 | 32/902 (3.5%) | 36 |
| Local tissue reaction; formation of fibrotic tissue; cyst formation | 15/908 (1.7%) | 20 | 16/902 (1.8%) | 16 |
| Tumor | 33/908 (3.6%) | 40 | 35/902 (3.9%) | 48 |
| Nervous system disorders | ||||
| Concussion | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Delirium | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Depression | 4/908 (0.4%) | 4 | 4/902 (0.4%) | 4 |
| Dimentia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Epilepsy | 4/908 (0.4%) | 4 | 4/902 (0.4%) | 5 |
| Orthostatic intolerance | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Parkinson's disease | 4/908 (0.4%) | 4 | 2/902 (0.2%) | 2 |
| Radicular syndrome | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Sclerosis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Sleep Apnea | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| Product Issues | ||||
| Inappropriate mode switch | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Inappropriate shocks | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Lead Fracture | 2/908 (0.2%) | 2 | 1/902 (0.1%) | 1 |
| Lead migration, dislodgment or poor lead placement | 31/908 (3.4%) | 37 | 36/902 (4%) | 39 |
| Loss of Capture | 3/908 (0.3%) | 3 | 6/902 (0.7%) | 6 |
| Mechanical malfunction of the pacing lead | 2/908 (0.2%) | 3 | 1/902 (0.1%) | 1 |
| Oversensing | 3/908 (0.3%) | 4 | 2/902 (0.2%) | 2 |
| Pacemaker Mediated Tachycardia | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Pacing Lead Impedance Out of Range | 3/908 (0.3%) | 3 | 3/902 (0.3%) | 4 |
| Pulse Generator Reset | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Undersensing | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Psychiatric disorders | ||||
| Altered Mental Status | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Renal and urinary disorders | ||||
| Cardiac or venous perforation | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Hematuria | 1/908 (0.1%) | 2 | 0/902 (0%) | 0 |
| Kidney Stones | 1/908 (0.1%) | 2 | 0/902 (0%) | 0 |
| Kidney disease | 8/908 (0.9%) | 8 | 7/902 (0.8%) | 9 |
| Macrohematuria | 1/908 (0.1%) | 2 | 0/902 (0%) | 0 |
| Nephrocalcinosis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Renal Disease | 11/908 (1.2%) | 12 | 20/902 (2.2%) | 20 |
| Renal failure | 16/908 (1.8%) | 17 | 21/902 (2.3%) | 22 |
| Ureteral Obstruction | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Urinary Retention | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Urinary Track Disease | 6/908 (0.7%) | 6 | 5/902 (0.6%) | 8 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchitis | 5/908 (0.6%) | 5 | 5/902 (0.6%) | 5 |
| Chronic obstructive pulmonary disease | 10/908 (1.1%) | 18 | 17/902 (1.9%) | 21 |
| Pleurisy | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Pneumonia | 52/908 (5.7%) | 58 | 36/902 (4%) | 41 |
| Pulmonary edema | 14/908 (1.5%) | 15 | 16/902 (1.8%) | 24 |
| Respiratory Disease | 11/908 (1.2%) | 13 | 11/902 (1.2%) | 15 |
| Skin and subcutaneous tissue disorders | ||||
| Abscess | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Erythema | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Surgical and medical procedures | ||||
| Colposcopy | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Coronary artery bypass surgery | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 3 |
| Endoscopic Retrograde Cholangiopancreatography | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Iron Infusion | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Percutaneous Coronary Intervention | 27/908 (3%) | 32 | 19/902 (2.1%) | 27 |
| Planned Lead Revision | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Planned Pulse Generator Replacement | 191/908 (21%) | 201 | 306/902 (33.9%) | 335 |
| Pulse Generator Pocket Revision | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 3 |
| Surgery | 77/908 (8.5%) | 89 | 80/902 (8.9%) | 101 |
| Vascular disorders | ||||
| Aneurysm | 7/908 (0.8%) | 10 | 4/902 (0.4%) | 4 |
| Cerebrovascular Accident | 5/908 (0.6%) | 5 | 9/902 (1%) | 10 |
| Coronary artery disease | 5/908 (0.6%) | 5 | 4/902 (0.4%) | 5 |
| Deep vein thrombosis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Fluid accumulation | 26/908 (2.9%) | 32 | 35/902 (3.9%) | 39 |
| Lim Ischemia | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Peripheral Arterial Occlusive Disease | 3/908 (0.3%) | 3 | 2/902 (0.2%) | 2 |
| Peripheral artery disease | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Stroke | 21/908 (2.3%) | 27 | 26/902 (2.9%) | 29 |
| Transient Ischemic Attack | 16/908 (1.8%) | 18 | 26/902 (2.9%) | 28 |
| Venous occlusion | 2/908 (0.2%) | 3 | 3/902 (0.3%) | 3 |
Other (Not Including Serious) Adverse Events |
||||
| RV Pacing | Biventricular Pacing | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 451/908 (49.7%) | 507/902 (56.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 5/908 (0.6%) | 5 | 4/902 (0.4%) | 4 |
| Bicytopenia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Epistaxis | 1/908 (0.1%) | 2 | 3/902 (0.3%) | 3 |
| Hematochezia | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Hypereosinophilia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Hyperkalemia | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Thromboemboli | 3/908 (0.3%) | 3 | 5/902 (0.6%) | 5 |
| Cardiac disorders | ||||
| Acute Coronary Syndrome | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Arrhythmia | 96/908 (10.6%) | 119 | 107/902 (11.9%) | 135 |
| Arteritis | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Bigeminy | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Cardiac arrest | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Chest Pain | 24/908 (2.6%) | 29 | 31/902 (3.4%) | 43 |
| Dyspnea | 38/908 (4.2%) | 47 | 47/902 (5.2%) | 55 |
| Exacerbation of heart failure | 23/908 (2.5%) | 24 | 23/902 (2.5%) | 23 |
| Heart block | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Hypertension | 8/908 (0.9%) | 9 | 13/902 (1.4%) | 15 |
| Hypotension | 7/908 (0.8%) | 9 | 8/902 (0.9%) | 8 |
| Mitral Regurgitation | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Myocardial infarction | 9/908 (1%) | 9 | 4/902 (0.4%) | 4 |
| Palpitations | 7/908 (0.8%) | 8 | 4/902 (0.4%) | 6 |
| Percutaneous Coronary Intervention | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Rise in threshold and exit block | 12/908 (1.3%) | 12 | 27/902 (3%) | 31 |
| Shortness of Breath | 11/908 (1.2%) | 11 | 7/902 (0.8%) | 9 |
| Valve damage | 10/908 (1.1%) | 14 | 4/902 (0.4%) | 4 |
| Ear and labyrinth disorders | ||||
| Tinnitus | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Vertigo | 3/908 (0.3%) | 3 | 2/902 (0.2%) | 3 |
| Endocrine disorders | ||||
| Diabetes | 12/908 (1.3%) | 12 | 13/902 (1.4%) | 14 |
| Hyperlipidemia | 2/908 (0.2%) | 2 | 1/902 (0.1%) | 1 |
| Hypoglycemia | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Toxic multinodular goitre | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Eye disorders | ||||
| Cataract | 7/908 (0.8%) | 7 | 5/902 (0.6%) | 7 |
| Galucoma | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Macular Degeneration | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| Constipation | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 3 |
| Diverticulitis | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Nausea | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Pancreatitis | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Ulcer | 3/908 (0.3%) | 3 | 0/902 (0%) | 0 |
| Abdominal pain | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Antral gastritis | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Diarrhea | 2/908 (0.2%) | 3 | 1/902 (0.1%) | 1 |
| Gastroenteritis | 3/908 (0.3%) | 4 | 2/902 (0.2%) | 2 |
| Hernia | 6/908 (0.7%) | 6 | 5/902 (0.6%) | 6 |
| Ulcerative colitis | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| General disorders | ||||
| Cold | 3/908 (0.3%) | 3 | 1/902 (0.1%) | 1 |
| Dizziness | 19/908 (2.1%) | 19 | 13/902 (1.4%) | 13 |
| Drug Toxicity | 1/908 (0.1%) | 2 | 3/902 (0.3%) | 3 |
| Dysphonia | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Esophagitis | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| Fever | 4/908 (0.4%) | 4 | 5/902 (0.6%) | 6 |
| Genital Prolapse | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Hospitalization for non-cardiac diseases | 24/908 (2.6%) | 26 | 18/902 (2%) | 21 |
| Influenza | 2/908 (0.2%) | 2 | 1/902 (0.1%) | 1 |
| Pain | 61/908 (6.7%) | 87 | 53/902 (5.9%) | 64 |
| Prolapse | 0/908 (0%) | 0 | 1/902 (0.1%) | 2 |
| Shingles | 3/908 (0.3%) | 3 | 1/902 (0.1%) | 1 |
| Short Loss of Consciousness | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Stenosis | 4/908 (0.4%) | 4 | 4/902 (0.4%) | 4 |
| Syncope | 12/908 (1.3%) | 14 | 12/902 (1.3%) | 13 |
| Tremor | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Weakness | 3/908 (0.3%) | 3 | 1/902 (0.1%) | 1 |
| Worsening of General Patient's Condition | 51/908 (5.6%) | 61 | 50/902 (5.5%) | 54 |
| Hepatobiliary disorders | ||||
| Dysfibrinogenemia | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Gallbladder disease | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Gallstones | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Immune system disorders | ||||
| Allergy | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| Infections and infestations | ||||
| Infection | 27/908 (3%) | 33 | 53/902 (5.9%) | 65 |
| Sepsis | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Accidental injury | 4/908 (0.4%) | 4 | 10/902 (1.1%) | 10 |
| Acute hemorrhage/bleeding | 8/908 (0.9%) | 9 | 15/902 (1.7%) | 16 |
| Air emboli | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| Amputation | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Asystole during implant | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Coronary Sinus Cannulation Failure | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Cardiac or venous perforation | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 3 |
| Cardiac tamponade | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Cardiac/coronary sinus dissection | 0/908 (0%) | 0 | 8/902 (0.9%) | 8 |
| Coronary sinus or cardiac vein thrombosis | 0/908 (0%) | 0 | 8/902 (0.9%) | 8 |
| Erosion | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Excessive bleeding | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Extracardiac stimulation (phrenic nerve, diaphragm, chest wall) | 14/908 (1.5%) | 14 | 77/902 (8.5%) | 95 |
| Fall | 25/908 (2.8%) | 29 | 31/902 (3.4%) | 34 |
| Hematoma/seroma formation | 13/908 (1.4%) | 13 | 29/902 (3.2%) | 31 |
| Inverted connection of RV and LV Leads | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Laceration | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Pericardial effusion | 2/908 (0.2%) | 2 | 1/902 (0.1%) | 1 |
| Pneumothorax | 6/908 (0.7%) | 6 | 8/902 (0.9%) | 8 |
| Steal Syndrome | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Trauma | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 5/908 (0.6%) | 5 | 1/902 (0.1%) | 1 |
| Bone fracture | 15/908 (1.7%) | 15 | 9/902 (1%) | 9 |
| Carpal tunnel syndrome | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Coxarthrosis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Gonarthrosis | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Gout | 2/908 (0.2%) | 2 | 6/902 (0.7%) | 7 |
| Hypertonia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Tendinitis | 3/908 (0.3%) | 3 | 1/902 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Cancer | 11/908 (1.2%) | 11 | 11/902 (1.2%) | 11 |
| Local tissue reaction; formation of fibrotic tissue; cyst formation | 8/908 (0.9%) | 8 | 3/902 (0.3%) | 3 |
| Tumor | 12/908 (1.3%) | 14 | 15/902 (1.7%) | 15 |
| Nervous system disorders | ||||
| Depression | 3/908 (0.3%) | 3 | 2/902 (0.2%) | 2 |
| Epilepsy | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Facial nerve paralysis | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Parethesia | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Parkinson's disease | 3/908 (0.3%) | 4 | 5/902 (0.6%) | 5 |
| Sleep Apnea | 1/908 (0.1%) | 2 | 0/902 (0%) | 0 |
| Product Issues | ||||
| Decreased CRT pacing | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Inability to defibrillate | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Inappropriate mode switch | 1/908 (0.1%) | 2 | 1/902 (0.1%) | 1 |
| Inappropriate shocks | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Lead migration, dislodgment or poor lead placement | 26/908 (2.9%) | 27 | 42/902 (4.7%) | 42 |
| Loss of Capture | 6/908 (0.7%) | 6 | 8/902 (0.9%) | 9 |
| Mechanical malfunction of the pacing lead | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Oversensing | 6/908 (0.7%) | 7 | 6/902 (0.7%) | 6 |
| Pacemaker Mediated Tachycardia | 3/908 (0.3%) | 3 | 1/902 (0.1%) | 1 |
| Pacing Lead Impedance Out of Range | 2/908 (0.2%) | 2 | 4/902 (0.4%) | 5 |
| Pulse Generator Reset | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Undersensing | 5/908 (0.6%) | 5 | 4/902 (0.4%) | 4 |
| Renal and urinary disorders | ||||
| Elevated uric acid | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Hematuria | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| Kidney disease | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Prostatism | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Renal Disease | 4/908 (0.4%) | 4 | 6/902 (0.7%) | 6 |
| Renal failure | 2/908 (0.2%) | 2 | 5/902 (0.6%) | 5 |
| Urinary Retention | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Urinary Track Disease | 5/908 (0.6%) | 5 | 4/902 (0.4%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchitis | 6/908 (0.7%) | 6 | 4/902 (0.4%) | 4 |
| Chronic obstructive pulmonary disease | 5/908 (0.6%) | 6 | 12/902 (1.3%) | 12 |
| Nocturnal desaturation | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Pleurisy | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Pneumonia | 8/908 (0.9%) | 9 | 8/902 (0.9%) | 8 |
| Pulmonary edema | 5/908 (0.6%) | 7 | 1/902 (0.1%) | 1 |
| Respiratory Disease | 3/908 (0.3%) | 3 | 4/902 (0.4%) | 5 |
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Mastitis | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Rosacea on Face | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Seborrheic keratosis | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Surgical and medical procedures | ||||
| Colposcopy | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Medication Titration | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Percutaneous Coronary Intervention | 7/908 (0.8%) | 7 | 9/902 (1%) | 9 |
| Planned Lead Revision | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Planned Pulse Generator Replacement | 9/908 (1%) | 9 | 15/902 (1.7%) | 15 |
| Pulse Generator Pocket Revision | 0/908 (0%) | 0 | 2/902 (0.2%) | 2 |
| Surgery | 52/908 (5.7%) | 58 | 52/902 (5.8%) | 64 |
| Vascular disorders | ||||
| Aneurysm | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
| Cerebrovascular Accident | 3/908 (0.3%) | 3 | 2/902 (0.2%) | 3 |
| Coronary artery disease | 1/908 (0.1%) | 1 | 3/902 (0.3%) | 3 |
| Deep vein thrombosis | 1/908 (0.1%) | 1 | 2/902 (0.2%) | 2 |
| Fluid accumulation | 23/908 (2.5%) | 24 | 24/902 (2.7%) | 25 |
| Hemorrhoids | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Lim Ischemia | 0/908 (0%) | 0 | 1/902 (0.1%) | 1 |
| Peripheral Arterial Occlusive Disease | 2/908 (0.2%) | 2 | 0/902 (0%) | 0 |
| Stroke | 3/908 (0.3%) | 3 | 2/902 (0.2%) | 2 |
| Transient Ischemic Attack | 11/908 (1.2%) | 14 | 12/902 (1.3%) | 12 |
| Varicose Veins | 1/908 (0.1%) | 1 | 0/902 (0%) | 0 |
| Venous occlusion | 1/908 (0.1%) | 1 | 1/902 (0.1%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Pascale Ducloux, Clinical Manager |
|---|---|
| Organization | St Jude Medical |
| Phone | +3227746709 |
| pducloux@sjm.com |
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT00187278
Other Study ID Numbers:
- CR03006HF
First Posted:
Sep 16, 2005
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2021