Model 4396 Left Ventricular (LV) Lead Chronic Performance Study
Attain Ability® Family Left Ventricular Lead Chronic Performance Study
1 other identifier
observational
366
3 countries
52
Brief Summary
Lead survivability will be summarized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
Longer than P75 for all trials
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2021
CompletedFebruary 17, 2021
February 1, 2021
8.8 years
May 25, 2011
February 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Model 4396 LV Lead-related complication rate
5 years
Secondary Outcomes (6)
Types of lead-related adverse device effects
5 years
Percent of subjects with changes in electrode programming
5 years
Number of fractures with and without loss of function
5 years
Bipolar electrical performance at 1 year
1 year
Bipolar pacing impedance
1 year
- +1 more secondary outcomes
Eligibility Criteria
Patients implanted with a 4396 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
You may not qualify if:
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive an Attain Ability Model 4396 LV lead
- Patient within 30 day post implant enrollment window
- Patient who is, or is expected to be inaccessible for follow-up
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (52)
Southwest EP Clinic
Gilbert, Arizona, 85295, United States
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, 92270, United States
COR Healthcare
Torrance, California, 90503, United States
Cardiovascular Consultants Medical Group
Van Nuys, California, 91405, United States
Colorado Heart and Vascular, PC
Lakewood, Colorado, 80228, United States
Yale University
New Haven, Connecticut, 06519, United States
MedStar Southern Maryland Hospital Center
Washington D.C., District of Columbia, 20010, United States
Bradenton Cardiology
Bradenton, Florida, 34205, United States
Baptist Heart Specialists
Jacksonville, Florida, 32216, United States
Indiana University Health - Methodist Research Institute
Indianapolis, Indiana, 46202, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Louisville Cardiology Group
Louisville, Kentucky, 40207, United States
Cenla Heart Specialists
Alexandria, Louisiana, 71301, United States
Our Lady of the Lake Office of Research
Baton Rouge, Louisiana, 70808, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Metropolitan Cardiology Consultants PA
Coon Rapids, Minnesota, 55433, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
North Memorial Heart and Vascular Institute
Robbinsdale, Minnesota, 55422, United States
HealthCare Partners Medical Group
Saint Louis Park, Minnesota, 55416, United States
Saint Lukes Health System
Kansas City, Missouri, 64111, United States
Washington University
St Louis, Missouri, 63110, United States
Patients First Health Care LLC
Washington, Missouri, 63090, United States
New Jersey Cardiology Associates
West Orange, New Jersey, 07052, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
NYU Langone Medical Center
New York, New York, 10016, United States
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
Central New York Cardiology
Utica, New York, 13501, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610, United States
The Christ Hospital Health Network
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Health Network
Bethlehem, Pennsylvania, 18017, United States
Medicor Associates
Erie, Pennsylvania, 16507, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17603, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Baylor Research Institute
Dallas, Texas, 75206, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Baylor Research Institute
Plano, Texas, 75093, United States
STAR Clinical Trials
San Antonio, Texas, 78229, United States
EP Heart LLC
The Woodlands, Texas, 77384, United States
The University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
Queen's University & Kingston General Hospital
Kingston, Ontario, K7L 3N6, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu
Montreal, Quebec, H2W 1T8, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, G1V 4G5, Canada
Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2011
First Posted
May 27, 2011
Study Start
May 1, 2011
Primary Completion
March 2, 2020
Study Completion
February 4, 2021
Last Updated
February 17, 2021
Record last verified: 2021-02