QuickFlex Micro Left Ventricular Lead Post Approval Study
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01179477
Collaborator
(none)
1,930
77
84
25.1
0.3
Study Details
Study Description
Brief Summary
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The primary endpoints of the study are:
-
Freedom from LV lead-related complications at 5 years
-
LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years
Study Design
Study Type:
Observational
Actual Enrollment
:
1930 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
Actual Study Start Date
:
Sep 1, 2010
Actual Primary Completion Date
:
Sep 1, 2017
Actual Study Completion Date
:
Sep 1, 2017
Outcome Measures
Primary Outcome Measures
- Percent of Participants Alive and Without a Left Ventricular Lead-related Complication [5 years]
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
- Left Ventricular Bipolar Pacing Capture Threshold [5 years]
Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study
-
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
-
Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
-
Have a life expectancy of less than 5 years due to any condition
-
Be less than 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiovascular Associates P.C. | Birmingham | Alabama | United States | 35213 |
| 2 | University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | United States | 35294 |
| 3 | Heart Center Research, LLC. | Huntsville | Alabama | United States | 35801 |
| 4 | Alaska Heart Institute | Anchorage | Alaska | United States | 99508 |
| 5 | Arizona Arrhythmia Research Center | Phoenix | Arizona | United States | 85013 |
| 6 | Arizona Arrhythmia Consultants | Scottsdale | Arizona | United States | 85252 |
| 7 | Arkansas Cardiology | Little Rock | Arkansas | United States | 72205 |
| 8 | St. Vincent Heart Clinic Arkansas | Little Rock | Arkansas | United States | 72205 |
| 9 | Arkansas Heart Hospital | Little Rock | Arkansas | United States | 72211 |
| 10 | Northwest Cardiology | Springdale | Arkansas | United States | 72764 |
| 11 | Glendale Memorial Hospital and Medical Center | Glendale | California | United States | 91206 |
| 12 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 13 | Regional Cardiology Associates | Sacramento | California | United States | 95819 |
| 14 | University of California at San Diego (UCSD) Medical Center | San Diego | California | United States | 92118 |
| 15 | Claudio Bonometti MD, Inc | Santa Barbara | California | United States | 93105 |
| 16 | Los Angeles Biomedical Research Institute at Harbor-UCLA | Torrance | California | United States | 90502 |
| 17 | Christiana Hospital | Newark | Delaware | United States | 19713 |
| 18 | Shands Jacksonville | Jacksonville | Florida | United States | 32209 |
| 19 | Naushad Shaik, MD | Kissimmee | Florida | United States | 32804 |
| 20 | Munroe Regional Medical Center | Ocala | Florida | United States | 34471 |
| 21 | Usman R. Siddiqui, MD | Orlando | Florida | United States | 32803 |
| 22 | Orlando Heart Center | Orlando | Florida | United States | 32806 |
| 23 | Brevard Cardiovascular Research Associates, Inc. | Rockledge | Florida | United States | 32955 |
| 24 | University of South Florida, Cardiovascular Services | Tampa | Florida | United States | 33606 |
| 25 | Athens Regional Medical Center | Athens | Georgia | United States | 30306 |
| 26 | St. Joseph's Hospital | Atlanta | Georgia | United States | 30045 |
| 27 | Redmond Regional Medical Center | Rome | Georgia | United States | 30165 |
| 28 | Prairie Education and Research Cooperative | Springfield | Illinois | United States | 62701 |
| 29 | Parkview Research Center | Fort Wayne | Indiana | United States | 46805 |
| 30 | The Heart Group | Newburgh | Indiana | United States | 47630 |
| 31 | Iowa Heart Center | West Des Moines | Iowa | United States | 50266 |
| 32 | Mid-America Cardiology Associates, PC | Kansas City | Kansas | United States | 66160 |
| 33 | King's Daughters Medical Center | Ashland | Kentucky | United States | 41101 |
| 34 | Central Baptist Hospital | Lexington | Kentucky | United States | 40503 |
| 35 | Norton Bluegrass Heart Specialists | Louisville | Kentucky | United States | 40217 |
| 36 | Peninsula Cardiology Associates, P.A. | Salisbury | Maryland | United States | 21804 |
| 37 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 38 | Trinity Health-Michigan d/b/a Michigan Heart | Ann Arbor | Michigan | United States | 48197 |
| 39 | Thoracic Cardio Healthcare Found. (aka Sparrow Research) | Lansing | Michigan | United States | 48912 |
| 40 | MidMichigan Physicians Group | Midland | Michigan | United States | 48640 |
| 41 | Jackson Heart Clinic | Jackson | Mississippi | United States | 39216 |
| 42 | Cardiology Associates of North Mississippi | Tupelo | Mississippi | United States | 38801 |
| 43 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 44 | Heart Consultants P.C. | Omaha | Nebraska | United States | 68122 |
| 45 | AtlantiCare Regional Medical Center | Pomona | New Jersey | United States | 08240 |
| 46 | Lourdes Cardiology Services | Voorhees | New Jersey | United States | 08043 |
| 47 | New Jersey Cardiology Associates | West Orange | New Jersey | United States | 07052 |
| 48 | Lenox Hill Hospital | New York | New York | United States | 10028 |
| 49 | LeBauer HeartCare | Greensboro | North Carolina | United States | 27401 |
| 50 | Wake Forest University Medical Center Clinical Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 51 | Primed Cardiology/Kettering Medical Center Network | Kettering | Ohio | United States | 45429 |
| 52 | Regional Cardiovascular Medical Center | Steubenville | Ohio | United States | 43953 |
| 53 | The Toledo Hospital | Toledo | Ohio | United States | 43615 |
| 54 | Toledo Clinic | Toledo | Ohio | United States | 43623 |
| 55 | St. Elizabeth Health Center | Youngstown | Ohio | United States | 44505 |
| 56 | Providence Heart and Vascular Institute | Portland | Oregon | United States | 97220 |
| 57 | Tri-State Medical Group Cardiology | Beaver | Pennsylvania | United States | 15009 |
| 58 | Capital Cardiovascular Associates | Camp Hill | Pennsylvania | United States | 17011 |
| 59 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 60 | Donald Guthrie Foundation for Education and Research | Sayre | Pennsylvania | United States | 18840 |
| 61 | WellSpan Health | York | Pennsylvania | United States | 17405 |
| 62 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 63 | Cardiology Consultants | Johnson City | Tennessee | United States | 37601 |
| 64 | Methodist University Hospital | Memphis | Tennessee | United States | 38104 |
| 65 | The Stern Cardiovascular Foundation | Memphis | Tennessee | United States | 38120 |
| 66 | Texas Cardiac Arrhythmia | Austin | Texas | United States | 78705 |
| 67 | HeartPlace | Bedford | Texas | United States | 76021 |
| 68 | Advanced Heart Care | Plano | Texas | United States | 75093 |
| 69 | South Texas Cardiovascular Consultants | San Antonio | Texas | United States | 78201 |
| 70 | Brooke Army Medical Center | San Antonio | Texas | United States | 78234 |
| 71 | Cardiovascular Associates of East Texas | Tyler | Texas | United States | 75701 |
| 72 | McKay-Dee Heart Services | Ogden | Utah | United States | 84403 |
| 73 | University of Utah Hospital | Salt Lake City | Utah | United States | 84132 |
| 74 | Cardiovascular Associates Ltd | Chesapeake | Virginia | United States | 23320 |
| 75 | Charleston Area Medical Center | Charleston | West Virginia | United States | 25304 |
| 76 | St. Mary's Hospital | Madison | Wisconsin | United States | 53715 |
| 77 | Cardiac Rhythm Specialists, S.C. | Milwaukee | Wisconsin | United States | 53211 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Clay Cohorn, Abbott Medical Devices
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01179477
Other Study ID Numbers:
- CRD561
First Posted:
Aug 11, 2010
Last Update Posted:
Aug 12, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Per the clinical investigation protocol, IDE subjects (n=54) who did not consent to roll over into the post approval study (PAS) at sites participating in the post approval study, were included in primary endpoint analyses. Since these subjects are not enrolled into the PAS, they are not reflected in the participant flow. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Arm/Group Description | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years. |
| Period Title: Overall Study | |
| STARTED | 1930 |
| COMPLETED | 843 |
| NOT COMPLETED | 1087 |
Baseline Characteristics
| Arm/Group Title | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Arm/Group Description | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years. |
| Overall Participants | 1930 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
68.7
(11.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
529
27.4%
|
| Male |
1401
72.6%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Asian |
8
0.4%
|
| American Indian or Alaska Native |
2
0.1%
|
| Black or African American |
197
10.2%
|
| Hispanic or Latino |
67
3.5%
|
| Native Hawaiian/Pacific Islander |
2
0.1%
|
| Other |
8
0.4%
|
| White |
1646
85.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
1930
100%
|
| Left Ventricular Ejection Fraction (Percent of blood ejected) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Percent of blood ejected] |
25.1
(7.6)
|
| Intrinsic QRS duration (ms) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [ms] |
152.0
(25.2)
|
| New York Heart Association (NYHA) Classification at Baseline (Count of Participants) | |
| Class I |
19
1%
|
| Class II |
175
9.1%
|
| Class III |
1672
86.6%
|
| Class IV |
61
3.2%
|
| Unknown |
3
0.2%
|
| Cardiomyopathy (Count of Participants) | |
| Ischemic |
1131
58.6%
|
| Non-ischemic |
799
41.4%
|
Outcome Measures
| Title | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication |
|---|---|
| Description | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol). |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population for Primary Endpoint #1 includes newly enrolled and IDE rollover subjects with an attempted implant of the QuickFlex μ LV lead (n=1,930) and subjects from the IDE sites that agreed to participate in the post-approval study, but did not consent to rollover into the post-approval study (n=54), for a total of 1,984 subjects. |
| Arm/Group Title | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Arm/Group Description | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years. |
| Measure Participants | 1984 |
| Count of Participants [Participants] |
1902
98.5%
|
| Title | Left Ventricular Bipolar Pacing Capture Threshold |
|---|---|
| Description | Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up |
| Time Frame | 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects included in this analysis are only those who have left ventricular bipolar pacing capture threshold values reported a the 5-year visit. Of the 843 who completed the 5 year visit, only 774 had analzable data. |
| Arm/Group Title | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Arm/Group Description | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years. |
| Measure Participants | 774 |
| Mean (Standard Deviation) [Volts] |
2.04
(1.6)
|
Adverse Events
| Time Frame | Complications and observations post implant through 5 years | |
|---|---|---|
| Adverse Event Reporting Description | Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning). An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming) | |
| Arm/Group Title | Subjects Implanted With a New QuickFlex μ Lead | |
| Arm/Group Description | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years. | |
All Cause Mortality |
||
| Subjects Implanted With a New QuickFlex μ Lead | ||
| Affected / at Risk (%) | # Events | |
| Total | 542/1930 (28.1%) | |
Serious Adverse Events |
||
| Subjects Implanted With a New QuickFlex μ Lead | ||
| Affected / at Risk (%) | # Events | |
| Total | 258/1930 (13.4%) | |
| Infections and infestations | ||
| Infection | 24/1930 (1.2%) | 24 |
| Erosion | 2/1930 (0.1%) | 2 |
| Endocarditis | 1/1930 (0.1%) | 1 |
| RV Endocarditis | 1/1930 (0.1%) | 1 |
| RV Infection | 1/1930 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Lead Dislodgement or Migration | 62/1930 (3.2%) | 63 |
| Diaphragmatic/Phrenic Nerve Stimulation | 16/1930 (0.8%) | 16 |
| Dizziness | 1/1930 (0.1%) | 1 |
| Endocarditis | 1/1930 (0.1%) | 1 |
| Induced Atrial or Ventricular Arrhythmias | 1/1930 (0.1%) | 1 |
| Pain/Discomfort At Incision Site | 2/1930 (0.1%) | 2 |
| Pericardial Effusion | 2/1930 (0.1%) | 2 |
| RA Cardiac/Coronary Sinus Perforation | 1/1930 (0.1%) | 1 |
| RA Diaphragmatic/Phrenic Nerve Stimulation | 1/1930 (0.1%) | 1 |
| RV Lead Dislodgement or Migration | 31/1930 (1.6%) | 32 |
| RV Cardiac/Coronary Sinus Perforation | 3/1930 (0.2%) | 3 |
| RV Cardiac Tamponade | 1/1930 (0.1%) | 1 |
| RV Pectoral Stimulation | 1/1930 (0.1%) | 1 |
| Procedure Hematoma/Seroma | 9/1930 (0.5%) | 9 |
| Procedure Pneumothorax/Hemothorax | 7/1930 (0.4%) | 7 |
| Procedural Pericardial Effusion | 3/1930 (0.2%) | 3 |
| Procedural Cardiac/Coronary Sinus Perforation | 2/1930 (0.1%) | 2 |
| Procedural Cardiac Arrest | 1/1930 (0.1%) | 1 |
| Procedural Cardiac Tamponade | 1/1930 (0.1%) | 1 |
| Procedural Deep Vein Thrombosis | 1/1930 (0.1%) | 1 |
| Procedural Device Migration | 1/1930 (0.1%) | 1 |
| Procedural Guidewire Stuck In LV Lead | 1/1930 (0.1%) | 1 |
| Procedural Lead Dislodgement or Migration | 1/1930 (0.1%) | 1 |
| Procedural Pleural Effusion | 1/1930 (0.1%) | 1 |
| Procedural Skin Injury At PG Pocket | 1/1930 (0.1%) | 1 |
| Product Issues | ||
| Loss of Capture | 9/1930 (0.5%) | 9 |
| Elevated Pacing Thresholds | 8/1930 (0.4%) | 8 |
| Abnormal LV Lead Pacing Impedance <= 200 OHMS or >= 2000 OHMS | 3/1930 (0.2%) | 3 |
| Lead Fracture | 1/1930 (0.1%) | 1 |
| Lead Insulation Damage | 1/1930 (0.1%) | 1 |
| Premature Battery Depletion | 8/1930 (0.4%) | 8 |
| Suspected Generator Malfunction | 4/1930 (0.2%) | 4 |
| LV Lead Loss of Capture | 1/1930 (0.1%) | 1 |
| RA Lead Dislodgement or Migration | 20/1930 (1%) | 22 |
| RA Abnormal Lead Impedance | 4/1930 (0.2%) | 4 |
| RA Lead Insulation Damage | 4/1930 (0.2%) | 4 |
| RA Loss of Capture | 2/1930 (0.1%) | 2 |
| RA Atrial Lead Noise | 1/1930 (0.1%) | 1 |
| RA Elevated Pacing Thresholds | 1/1930 (0.1%) | 1 |
| RA Oversensing | 1/1930 (0.1%) | 1 |
| RA Undersensing | 1/1930 (0.1%) | 1 |
| RV Elevated Pacing Thresholds | 9/1930 (0.5%) | 9 |
| RV Lead Fracture | 7/1930 (0.4%) | 7 |
| RV Lead Insulation Damage | 5/1930 (0.3%) | 5 |
| RV Abnormal Lead Impedance | 4/1930 (0.2%) | 4 |
| RV Loss of Capture | 2/1930 (0.1%) | 2 |
| RV Inappropriate Shock | 1/1930 (0.1%) | 1 |
| RV Oversensing | 1/1930 (0.1%) | 1 |
| RV Lead Unable to Defibrillate | 1/1930 (0.1%) | 1 |
| RV Undersensing | 1/1930 (0.1%) | 1 |
| Psychiatric disorders | ||
| Twiddler Syndrome | 3/1930 (0.2%) | 4 |
Other (Not Including Serious) Adverse Events |
||
| Subjects Implanted With a New QuickFlex μ Lead | ||
| Affected / at Risk (%) | # Events | |
| Total | 512/1930 (26.5%) | |
| Cardiac disorders | ||
| System/Pulse Generator Related Therapy For Non-Ventricular Rhythm | 23/1930 (1.2%) | 27 |
| System/Pulse Generator Related Idioventricular Rhythm Preventing Biventricular Pacing | 1/1930 (0.1%) | 1 |
| RV Lead Related Therapy For Non-Ventricular Rhythm | 6/1930 (0.3%) | 6 |
| Other Therapy For Non-Ventricular Rhythm | 6/1930 (0.3%) | 6 |
| General disorders | ||
| Other Pulmonary Edema | 2/1930 (0.1%) | 2 |
| Infections and infestations | ||
| Procedure Related Infection | 4/1930 (0.2%) | 4 |
| Other Infection | 1/1930 (0.1%) | 2 |
| Injury, poisoning and procedural complications | ||
| LV Diaphragmatic/Phrenic Nerve Stimulation | 145/1930 (7.5%) | 164 |
| LV Induced Atrial or Ventricular Arrhythmias | 2/1930 (0.1%) | 2 |
| LV Lead Dislodgement or Migration | 2/1930 (0.1%) | 2 |
| LV Cardiac/Coronary Sinus Dissection | 1/1930 (0.1%) | 1 |
| LV Coronary Sinus or Cardiac Vein Thrombosis | 1/1930 (0.1%) | 1 |
| RA Lead Related Lead Dislodgement or Migration | 1/1930 (0.1%) | 1 |
| RA Lead Related Myopotential Sensing | 1/1930 (0.1%) | 1 |
| RV Lead Related Bilateral Pleural Effusion | 1/1930 (0.1%) | 1 |
| RV Lead Related Myopotential Sensing | 1/1930 (0.1%) | 1 |
| RV Lead Related Pectoral Stimulation | 1/1930 (0.1%) | 1 |
| Procedure Related Hematoma/Seroma | 33/1930 (1.7%) | 33 |
| Procedure Related Cardiac/Coronary Sinus Dissection | 12/1930 (0.6%) | 12 |
| Procedure Related Atrial Arrhythmia | 3/1930 (0.2%) | 3 |
| Procedure Related Pericardial Effusion | 3/1930 (0.2%) | 3 |
| Procedure Related Bleeding And/or Hemoptysis | 2/1930 (0.1%) | 2 |
| Procedure Related Cardiac Vein Thrombus | 2/1930 (0.1%) | 2 |
| Procedure Related Part of The Delivery Tool Was Left In The Coronary Sinus/ Ventricle | 2/1930 (0.1%) | 2 |
| Procedure Related Pneumothorax/Hemothorax | 2/1930 (0.1%) | 2 |
| Procedure Related Pulmonary Edema | 2/1930 (0.1%) | 2 |
| Procedure Related Renal Failure or Injury | 2/1930 (0.1%) | 2 |
| Procedure Related Acute Left Arm Thrombophlebitis | 1/1930 (0.1%) | 1 |
| Procedure Related Cardiac/Coronary Sinus Perforation | 1/1930 (0.1%) | 1 |
| Procedure Related Decompensated Heart Failure | 1/1930 (0.1%) | 1 |
| Procedure Related Device Incision Erythema | 1/1930 (0.1%) | 1 |
| Procedure Related Excessive Bleeding | 1/1930 (0.1%) | 1 |
| Procedure Related Frozen Shoulder | 1/1930 (0.1%) | 1 |
| Procedure Related High DFT's | 1/1930 (0.1%) | 1 |
| Procedure Related Hypotension | 1/1930 (0.1%) | 1 |
| Procedure Related Hypotension Requiring Medical Intervention During CRT-D Implant | 1/1930 (0.1%) | 1 |
| Procedure Related Myocardial Infarction | 1/1930 (0.1%) | 1 |
| Procedure Related Pericarditis | 1/1930 (0.1%) | 1 |
| Other Pericardial Effusion | 3/1930 (0.2%) | 3 |
| Other Induced Atrial or Ventricular Arrhythmias | 2/1930 (0.1%) | 2 |
| Product Issues | ||
| LV Lead Elevated Pacing Thresholds | 214/1930 (11.1%) | 221 |
| LV Loss of Capture | 19/1930 (1%) | 20 |
| Abnormal LV Lead Pacing Impedance <= 200 Ω or >= 2000 Ω | 16/1930 (0.8%) | 17 |
| LV Lead Insulation Damage | 1/1930 (0.1%) | 1 |
| System/Pulse Generator Related Failed ICD Shock | 1/1930 (0.1%) | 1 |
| System/Pulse Generator Related Pacemaker Mediated Tachycardia | 1/1930 (0.1%) | 1 |
| RA Lead Related Oversensing | 9/1930 (0.5%) | 9 |
| RA Lead Related Abnormal Lead Impedance | 5/1930 (0.3%) | 5 |
| RA Lead Related Atrial Lead Noise | 3/1930 (0.2%) | 3 |
| RA Lead Related Elevated Pacing Thresholds | 3/1930 (0.2%) | 3 |
| RA Lead Related Lead Insulation Damage | 3/1930 (0.2%) | 3 |
| RA Lead Related Loss of Capture | 2/1930 (0.1%) | 2 |
| RA Lead Related Lead Fracture | 1/1930 (0.1%) | 1 |
| RA Lead Related Undersensing | 1/1930 (0.1%) | 1 |
| RV Lead Related Abnormal Lead Impedance | 3/1930 (0.2%) | 3 |
| RV Lead Related Lead Insulation Damage | 2/1930 (0.1%) | 2 |
| RV Lead Related Elevated Pacing Thresholds | 1/1930 (0.1%) | 1 |
| RV Lead Related Lead Externalization | 1/1930 (0.1%) | 1 |
| RV Lead Related Oversensing | 1/1930 (0.1%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Clay Cohorn, Clinical Program Director |
|---|---|
| Organization | Abbott |
| Phone | 972-309-8087 |
| clay.cohorn@abbott.com |
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01179477
Other Study ID Numbers:
- CRD561
First Posted:
Aug 11, 2010
Last Update Posted:
Aug 12, 2019
Last Verified:
Jul 1, 2019