PRomPT: Post-Myocardial Infarction Remodeling Prevention Therapy
Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT01213251
Collaborator
(none)
129
26
3
64
5
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Post-Myocardial Infarction Remodeling Prevention Therapy
Study Start Date
:
Dec 1, 2010
Actual Primary Completion Date
:
Oct 1, 2015
Actual Study Completion Date
:
Apr 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Site Pacing
|
Device: Single Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
|
| Experimental: Dual Site Pacing
|
Device: Dual Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- Change in Left Ventricular End Diastolic Volume (LVEDV) [Baseline - 18 Month Follow Up Visit]
Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.
Secondary Outcome Measures
- Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events [18 months post-implant]
Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.
- Frequency of Hospitalization for Cardiovascular Events [Baseline - 18 Month Follow Up Visit]
Number of hospitalizations related to cardiovascular events.
- Change in New York Heart Association (NYHA) Functional Class [Baseline - 18 Month Follow Up Visit]
The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as "Improved". Similarly for "Worsened" (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as "No Change". Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.
- Change in 6-minute Walk Test Distance [1 Month - 18 Month Follow Up Visit]
Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit. Change is defined as month 18 minus baseline. Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.
- Change in Quality of Life [Baseline - 18 Month Follow Up Visit]
Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit. Change is defined as month 18 minus baseline. Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.
- Incidence of Sudden Cardiac Death and Total Mortality [18 Months post-randomization]
Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods. Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.
- Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes. [Baseline - 18 Month Follow Up Visit]
Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable. Variables resulting in statistical significant (p<0.05) are reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Myocardial Infarction (MI) within the past 10 days
-
Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L)
-
At least 18 years old
-
Willing to comply with the protocol
Exclusion Criteria:
-
Documented MI greater than 10 days
-
Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less than 30 milliliters/minute/1.73 square meter
-
Life expectancy less than 18 months, as determined by a physician
-
Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device
-
QRS duration greater than 120 milliseconds (ms)
-
Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure planned
-
Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia
-
Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is terminated electrically or pharmacologically
-
Permanent AF that is non self terminating, with cardioversion failed or not attempted within the past year
-
New York Heart Association (NYHA) Class IV
-
Non-ischemic cardiomyopathy
-
Pregnant or planning to become pregnant during the study
-
Enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from Medtronic, documenting that there is not a concern that co-enrollment could confound the results of this trial.
-
Breast feeding
-
Of a vulnerable population as determined by local law or requirement, or a physician
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Arrhythmia Consultants | Scottsdale | Arizona | United States | 85251 |
| 2 | Kaiser Permanente | Los Angeles | California | United States | 90027 |
| 3 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
| 4 | Lexington Cardiac Research Foundation | Lexington | Kentucky | United States | 40503 |
| 5 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 6 | Michigan Heart, PC | Ypsilanti | Michigan | United States | 48197 |
| 7 | Carolina Heart Specialists | Gastonia | North Carolina | United States | 28054 |
| 8 | Lindner Clinical Trial Center | Cincinnati | Ohio | United States | 45219 |
| 9 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 10 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 11 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 12 | The Chattanooga Heart Institute | Chattanooga | Tennessee | United States | 37404 |
| 13 | The Stern Cardiovascular Foundation | Germantown | Tennessee | United States | 38138 |
| 14 | Saint Thomas Research Institute, LLC | Nashville | Tennessee | United States | 37205 |
| 15 | Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | United States | 75226 |
| 16 | Delgado Cardiovascular Associates | Houston | Texas | United States | 77004 |
| 17 | Spokane Cardiology | Spokane | Washington | United States | 99204 |
| 18 | Rigshospitalet | Copenhagen | Denmark | ||
| 19 | Hôpital Cardiologique du Haut-Lévêque | Bordeaux-Pessac | France | ||
| 20 | Centre Hospitalier Régional Universitaire de Lille | Lille | France | ||
| 21 | Herzzentrum Leipzig GmbH | Leipzig | Germany | ||
| 22 | University Hospital Mannheim | Mannheim | Germany | ||
| 23 | Maygar Honvédség Honvédkorház | Budapest | Hungary | ||
| 24 | Semmelweis University Heart Center | Budapest | Hungary | ||
| 25 | Prince Salman Heart Centre | King Fahad Medical City | Saudi Arabia | ||
| 26 | Vychodoslovensky ustav srdcovych a cievnych chorob, a.s. | Kosice | Slovakia |
Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
- Principal Investigator: Gregg Stone, MD, Columbia University
- Principal Investigator: Angel Leon, MD, Emory University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT01213251
Other Study ID Numbers:
- PRomPT
First Posted:
Oct 1, 2010
Last Update Posted:
Dec 15, 2016
Last Verified:
Oct 1, 2016
Study Results
Participant Flow
| Recruitment Details | 3 patients exited study prior to randomization. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Site Pacing | Dual Site Pacing | Control |
|---|---|---|---|
| Arm/Group Description | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. | Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management. |
| Period Title: Overall Study | |||
| STARTED | 40 | 41 | 45 |
| COMPLETED | 34 | 37 | 34 |
| NOT COMPLETED | 6 | 4 | 11 |
Baseline Characteristics
| Arm/Group Title | Single Site Pacing | Dual Site Pacing | Control | Total |
|---|---|---|---|---|
| Arm/Group Description | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. | Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management. | Total of all reporting groups |
| Overall Participants | 40 | 41 | 45 | 126 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
59
(10)
|
60
(12)
|
54
(11)
|
58
(11)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
12
30%
|
9
22%
|
12
26.7%
|
33
26.2%
|
| Male |
28
70%
|
32
78%
|
33
73.3%
|
93
73.8%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||
| Asian |
0
0%
|
1
2.4%
|
0
0%
|
1
0.8%
|
| Black or African American |
3
7.5%
|
3
7.3%
|
5
11.1%
|
11
8.7%
|
| Hispanic or Latino |
0
0%
|
1
2.4%
|
3
6.7%
|
4
3.2%
|
| White or Caucasian |
19
47.5%
|
16
39%
|
18
40%
|
53
42.1%
|
| Not reportable per local laws or regulations |
18
45%
|
20
48.8%
|
19
42.2%
|
57
45.2%
|
| BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
28
(6)
|
30
(5)
|
29
(4)
|
29
(5)
|
| Systolic Blood Pressure (mmHg) (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
114
(16)
|
118
(21)
|
119
(17)
|
117
(18)
|
| Diastolic Blood Pressure (mmHg) (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
73
(11)
|
71
(12)
|
74
(11)
|
73
(11)
|
| Heart Rate from Physical Exam (BPM) (BPM) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [BPM] |
80
(15)
|
80
(13)
|
79
(14)
|
79
(14)
|
| Left Ventricular Ejection Fraction (LVEF) (%) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [%] |
43
(9)
|
43
(10)
|
45
(9)
|
44
(9)
|
| Left Ventricular End Diastolic Volume (LVEDV) (mL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mL] |
107
(25)
|
107
(31)
|
116
(29)
|
111
(29)
|
| Left Ventricular End Systolic Volume (LVESV) (mL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mL] |
62
(23)
|
62
(22)
|
65
(24)
|
63
(23)
|
| QRS Width (msec) (msec) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [msec] |
94
(17)
|
97
(17)
|
88
(13)
|
93
(16)
|
| NYHA (participants) [Number] | ||||
| I |
9
22.5%
|
12
29.3%
|
11
24.4%
|
32
25.4%
|
| II |
10
25%
|
10
24.4%
|
16
35.6%
|
36
28.6%
|
| III |
15
37.5%
|
12
29.3%
|
9
20%
|
36
28.6%
|
| IV |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Subject does not have heart failure |
6
15%
|
7
17.1%
|
8
17.8%
|
21
16.7%
|
| Missing |
0
0%
|
0
0%
|
1
2.2%
|
1
0.8%
|
| Minnesota Living with Heart Failure Questionnaire (MLWHF) (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
21
(25)
|
29
(26)
|
32
(29)
|
28
(27)
|
Outcome Measures
| Title | Change in Left Ventricular End Diastolic Volume (LVEDV) |
|---|---|
| Description | Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control. |
| Time Frame | Baseline - 18 Month Follow Up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included. |
| Arm/Group Title | Pooled Pacing | Control |
|---|---|---|
| Arm/Group Description | Subjects successfully implanted with a CRT-D device (either single or dual pacing). | Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management. |
| Measure Participants | 64 | 34 |
| Mean (95% Confidence Interval) [mL] |
16.4
|
15.8
|
| Title | Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events |
|---|---|
| Description | Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication. |
| Time Frame | 18 months post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included. |
| Arm/Group Title | Single Site Pacing | Dual Site Pacing |
|---|---|---|
| Arm/Group Description | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. |
| Measure Participants | 38 | 38 |
| System-Related Adverse Event |
0.59
|
0.68
|
| System Related Complication |
0.86
|
0.87
|
| Procedure Related Adverse Event |
0.57
|
0.66
|
| Procedure Related Complication |
0.84
|
0.84
|
| System Related or Procedure Related Complication |
0.79
|
0.82
|
| Title | Frequency of Hospitalization for Cardiovascular Events |
|---|---|
| Description | Number of hospitalizations related to cardiovascular events. |
| Time Frame | Baseline - 18 Month Follow Up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. |
| Arm/Group Title | Single Site Pacing | Dual Site Pacing | Control |
|---|---|---|---|
| Arm/Group Description | Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. | Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management. |
| Measure Participants | 38 | 37 | 45 |
| 0 |
27
67.5%
|
22
53.7%
|
30
66.7%
|
| 1 |
6
15%
|
9
22%
|
11
24.4%
|
| 2 |
3
7.5%
|
3
7.3%
|
0
0%
|
| 3 |
1
2.5%
|
1
2.4%
|
3
6.7%
|
| 4 |
0
0%
|
0
0%
|
0
0%
|
| 5 |
1
2.5%
|
1
2.4%
|
0
0%
|
| 6 |
0
0%
|
0
0%
|
0
0%
|
| 7 |
0
0%
|
0
0%
|
0
0%
|
| 8 |
0
0%
|
1
2.4%
|
0
0%
|
| 9 |
0
0%
|
0
0%
|
1
2.2%
|
| Title | Change in New York Heart Association (NYHA) Functional Class |
|---|---|
| Description | The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as "Improved". Similarly for "Worsened" (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as "No Change". Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control. |
| Time Frame | Baseline - 18 Month Follow Up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included. |
| Arm/Group Title | Pooled Pacing | Control |
|---|---|---|
| Arm/Group Description | Subjects successfully implanted with a CRT-D device (either single or dual pacing). | Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management. |
| Measure Participants | 68 | 33 |
| Improved |
26
65%
|
13
31.7%
|
| No Change |
25
62.5%
|
10
24.4%
|
| Worsened |
17
42.5%
|
10
24.4%
|
| Title | Change in 6-minute Walk Test Distance |
|---|---|
| Description | Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit. Change is defined as month 18 minus baseline. Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control. |
| Time Frame | 1 Month - 18 Month Follow Up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included. |
| Arm/Group Title | Pooled Pacing | Control |
|---|---|---|
| Arm/Group Description | Subjects successfully implanted with a CRT-D device (either single or dual pacing). | Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management. |
| Measure Participants | 63 | 28 |
| Mean (95% Confidence Interval) [meters] |
37.6
|
15.6
|
| Title | Change in Quality of Life |
|---|---|
| Description | Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit. Change is defined as month 18 minus baseline. Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control. |
| Time Frame | Baseline - 18 Month Follow Up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included. |
| Arm/Group Title | Pooled Pacing | Control |
|---|---|---|
| Arm/Group Description | Subjects successfully implanted with a CRT-D device (either single or dual pacing). | Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management. |
| Measure Participants | 69 | 32 |
| Mean (95% Confidence Interval) [units on a scale] |
0.4
|
-0.1
|
| Title | Incidence of Sudden Cardiac Death and Total Mortality |
|---|---|
| Description | Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods. Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control. |
| Time Frame | 18 Months post-randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. |
| Arm/Group Title | Pooled Pacing | Control |
|---|---|---|
| Arm/Group Description | Subjects successfully implanted with a CRT-D device (either single or dual pacing). | Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management. |
| Measure Participants | 75 | 45 |
| All-cause Death |
4.0
|
4.7
|
| Sudden-cardiac Death |
1.4
|
2.4
|
| Title | Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes. |
|---|---|
| Description | Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable. Variables resulting in statistical significant (p<0.05) are reported. |
| Time Frame | Baseline - 18 Month Follow Up Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included. |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included. |
| Measure Participants | 98 |
| Age |
-0.75
(0.26)
|
| Days from MI to Implant* |
-3.78
(1.64)
|
| Baseline LVEF |
-0.87
(0.35)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Single Site Pacing | Dual Site Pacing | Control | |||
| Arm/Group Description | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. | Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management. | |||
All Cause Mortality |
||||||
| Single Site Pacing | Dual Site Pacing | Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Single Site Pacing | Dual Site Pacing | Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/40 (55%) | 24/41 (58.5%) | 20/45 (44.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/40 (2.5%) | 2 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac disorders | ||||||
| Acute coronary syndrome | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Acute myocardial infarction | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 3/45 (6.7%) | 5 |
| Angina pectoris | 2/40 (5%) | 2 | 1/41 (2.4%) | 2 | 3/45 (6.7%) | 5 |
| Angina unstable | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 1/45 (2.2%) | 1 |
| Atrial fibrillation | 0/40 (0%) | 0 | 3/41 (7.3%) | 7 | 1/45 (2.2%) | 1 |
| Atrial flutter | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 2 | 0/45 (0%) | 0 |
| Atrioventricular block complete | 2/40 (5%) | 2 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Atrioventricular block second degree | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac aneurysm | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Cardiac arrest | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac failure congestive | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 4/45 (8.9%) | 6 |
| Cardiac perforation | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Cardiorenal syndrome | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Coronary artery disease | 2/40 (5%) | 2 | 1/41 (2.4%) | 1 | 1/45 (2.2%) | 1 |
| Decompensated Heart Failure | 2/40 (5%) | 4 | 5/41 (12.2%) | 13 | 6/45 (13.3%) | 6 |
| Dresslers syndrome | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Ischaemic cardiomyopathy | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Myocardial infarction | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 1/45 (2.2%) | 1 |
| Supraventricular tachycardia | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Ventricular extrasystoles | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Ventricular fibrillation | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Ventricular tachycardia | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Congenital, familial and genetic disorders | ||||||
| Gastrointestinal arteriovenous malformation | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Colitis ulcerative | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 2 |
| Duodenal ulcer haemorrhage | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Inguinal hernia | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Rectal haemorrhage | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| General disorders | ||||||
| Chest pain | 2/40 (5%) | 2 | 1/41 (2.4%) | 1 | 2/45 (4.4%) | 2 |
| Device infusion issue | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Device stimulation issue | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Implant site haemorrhage | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Lead dislodgement | 2/40 (5%) | 3 | 4/41 (9.8%) | 4 | 0/45 (0%) | 0 |
| Multi-organ failure | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Non-cardiac chest pain | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 4/45 (8.9%) | 4 |
| Undersensing | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Cholecystitis | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Infections and infestations | ||||||
| Appendicitis | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Diverticulitis | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Erysipelas | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Implant site infection | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Incision site infection | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Pneumonia | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 3/45 (6.7%) | 6 |
| Urinary tract infection | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Viral myocarditis | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Accidental overdose | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Coronary artery restenosis | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 2/45 (4.4%) | 2 |
| Lumbar vertebral fracture | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Investigations | ||||||
| International normalised ratio increased | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Fluid overload | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Hyponatraemia | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Malnutrition | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Joint effusion | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Vertebral foraminal stenosis | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Bladder transitional cell carcinoma | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Lung adenocarcinoma | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rectal adenoma | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Nervous system disorders | ||||||
| Dizziness | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Hypoxic-ischaemic encephalopathy | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Ischaemic stroke | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Lumbar radiculopathy | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Syncope | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Psychiatric disorders | ||||||
| Depression suicidal | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 2/40 (5%) | 2 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Acute prerenal failure | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Nephrolithiasis | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Renal failure | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Renal impairment | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute respiratory failure | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Dyspnoea | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Epistaxis | 2/40 (5%) | 3 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Haemoptysis | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Pleural effusion | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Pneumothorax | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Pulmonary oedema | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Respiratory failure | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis contact | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Vascular disorders | ||||||
| Aortic aneurysm | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Arterial stenosis | 1/40 (2.5%) | 1 | 2/41 (4.9%) | 2 | 1/45 (2.2%) | 1 |
| Arterial thrombosis | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Hypotension | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Orthostatic hypotension | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Subclavian steal syndrome | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Thrombosis | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Single Site Pacing | Dual Site Pacing | Control | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/40 (50%) | 25/41 (61%) | 27/45 (60%) | |||
| Blood and lymphatic system disorders | ||||||
| Increased tendency to bruise | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Thrombocytopenia | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Cardiac disorders | ||||||
| Angina pectoris | 2/40 (5%) | 2 | 1/41 (2.4%) | 1 | 2/45 (4.4%) | 2 |
| Angina unstable | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Atrial fibrillation | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Atrioventricular block complete | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Bradycardia | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac failure congestive | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Cardiomegaly | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 1/45 (2.2%) | 1 |
| Coronary artery disease | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Decompensated Heart Failure | 1/40 (2.5%) | 1 | 3/41 (7.3%) | 3 | 4/45 (8.9%) | 5 |
| Intracardiac thrombus | 1/40 (2.5%) | 1 | 3/41 (7.3%) | 3 | 1/45 (2.2%) | 1 |
| Palpitations | 2/40 (5%) | 2 | 1/41 (2.4%) | 1 | 1/45 (2.2%) | 1 |
| Sinus bradycardia | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Ventricular fibrillation | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Ventricular tachycardia | 2/40 (5%) | 2 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Endocrine disorders | ||||||
| Hypogonadism | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Eye disorders | ||||||
| Keratitis | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Constipation | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Dental discomfort | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Dyspepsia | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Dysphagia | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Large intestine polyp | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Nausea | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| General disorders | ||||||
| Adverse drug reaction | 1/40 (2.5%) | 1 | 3/41 (7.3%) | 3 | 0/45 (0%) | 0 |
| Chest pain | 2/40 (5%) | 2 | 3/41 (7.3%) | 3 | 2/45 (4.4%) | 2 |
| Device alarm issue | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Device capturing issue | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Device electrical impedance issue | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Device infusion issue | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Device malfunction | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Device occlusion | 0/40 (0%) | 0 | 1/41 (2.4%) | 3 | 0/45 (0%) | 0 |
| Device pacing issue | 4/40 (10%) | 4 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Device stimulation issue | 8/40 (20%) | 13 | 4/41 (9.8%) | 4 | 0/45 (0%) | 0 |
| Fatigue | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 1/45 (2.2%) | 1 |
| Implant site bruising | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Implant site oedema | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Implant site pain | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Implant site scar | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Implant site swelling | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Lead dislodgement | 2/40 (5%) | 2 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Medical device pain | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Non-cardiac chest pain | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 2/45 (4.4%) | 2 |
| Oedema peripheral | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Oversensing | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Peripheral swelling | 2/40 (5%) | 2 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Phantom shocks | 0/40 (0%) | 0 | 2/41 (4.9%) | 2 | 0/45 (0%) | 0 |
| Undersensing | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Vessel puncture site haematoma | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Hepatobiliary disorders | ||||||
| Cholelithiasis | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Immune system disorders | ||||||
| Drug hypersensitivity | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Infections and infestations | ||||||
| Acarodermatitis | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Bronchitis | 2/40 (5%) | 2 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Diverticulitis | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Echinococciasis | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Gastroenteritis norovirus | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Impetigo | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Implant site infection | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Influenza | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Accidental overdose | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Cardiac vein dissection | 0/40 (0%) | 0 | 2/41 (4.9%) | 2 | 0/45 (0%) | 0 |
| Cardiac vein perforation | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Contusion | 2/40 (5%) | 2 | 0/41 (0%) | 0 | 2/45 (4.4%) | 2 |
| Foreign body | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Incision site pain | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Laceration | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Ligament sprain | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Procedural pain | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Traumatic haematoma | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Wound dehiscence | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Investigations | ||||||
| Biopsy skin | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Blood pressure increased | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Blood urine present | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Body temperature increased | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| C-reactive protein increased | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Echocardiogram abnormal | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Hepatic enzyme increased | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| International normalised ratio increased | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 2 |
| Liver function test abnormal | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Gout | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Hypocalcaemia | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Hypokalaemia | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Hyponatraemia | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 1/40 (2.5%) | 1 | 3/41 (7.3%) | 3 | 0/45 (0%) | 0 |
| Musculoskeletal pain | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 2/45 (4.4%) | 2 |
| Myalgia | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 2/45 (4.4%) | 2 |
| Pain in extremity | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Renal adenoma | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Nervous system disorders | ||||||
| Cervicobrachial syndrome | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Dizziness | 2/40 (5%) | 2 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Headache | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Paraesthesia | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Sciatica | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Syncope | 3/40 (7.5%) | 3 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Psychiatric disorders | ||||||
| Acute stress disorder | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Stress | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Renal and urinary disorders | ||||||
| Haematuria | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Renal failure | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Reproductive system and breast disorders | ||||||
| Benign prostatic hyperplasia | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Menopausal symptoms | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Dyspnoea | 0/40 (0%) | 0 | 4/41 (9.8%) | 4 | 3/45 (6.7%) | 3 |
| Dyspnoea exertional | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Epistaxis | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Pulmonary hypertension | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Respiratory failure | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Sinus congestion | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Sleep apnoea syndrome | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis allergic | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Ingrowing nail | 1/40 (2.5%) | 2 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Photodermatosis | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 0/40 (0%) | 0 | 1/41 (2.4%) | 1 | 0/45 (0%) | 0 |
| Hypotension | 1/40 (2.5%) | 1 | 1/41 (2.4%) | 1 | 3/45 (6.7%) | 3 |
| Orthostatic hypotension | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Peripheral arterial occlusive disease | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
| Peripheral artery thrombosis | 0/40 (0%) | 0 | 0/41 (0%) | 0 | 1/45 (2.2%) | 1 |
| Venous stenosis | 1/40 (2.5%) | 1 | 0/41 (0%) | 0 | 0/45 (0%) | 0 |
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 | PRomPT Clinical Team |
|---|---|
| Organization | Medtronic plc |
| Phone | +1 800-328-2518 |
| MedtronicCRMtrials@medtronic.com |
Responsible Party:
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT01213251
Other Study ID Numbers:
- PRomPT
First Posted:
Oct 1, 2010
Last Update Posted:
Dec 15, 2016
Last Verified:
Oct 1, 2016