Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Completed
Conditions studied: Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
In brief
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.
Key facts
- Study ID
- NCT01596595
- Run by
- Boston Scientific Corporation
- People needed
- 1820
- Starts
- 2013-04-04
- Expected to finish
- 2020-02-18
- Last updated by the study team
- 2021-03-19
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- medically indicated for ICD/CRT-D
- received/plan to receive study lead
- willing for long-term follow-up
You may not qualify if…
- unwilling to comply with protocol
Where it is running
- Cardiovascular Consultants, LTD — Glendale, Arizona, United States
- Cardiovascular Associates of Mesa — Mesa, Arizona, United States
- Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
- Heart Clinic Arkansas — Little Rock, Arkansas, United States
- Providence St. Joseph Medical Center — Burbank, California, United States
- Palomar Medical Center — Escondido, California, United States
- California Heart Associates — Fountain Valley, California, United States
- Luc Sinh Nguyen, MD, FACC, Inc. — Fountain Valley, California, United States
- Providence Holy Cross Medical Center — Los Angeles, California, United States
- Cardiac Device Rhythm Specialists — Los Angeles, California, United States
- Comprehensive Cardiovascular Medical Group — Los Angeles, California, United States
- Desert Regional Medical Center — Palm Springs, California, United States
- Truong D. Duong, MD. A Medical Corporation — Riverside, California, United States
- San Diego Arrhythmia Associates — San Diego, California, United States
- Good Samaritan Hospital - San Jose — San Jose, California, United States
- Santa Barbara Cottage Hospital — Santa Barbara, California, United States
- Little Company of Mary Hospital — Torrance, California, United States
- University of Colorado Hospital — Aurora, Colorado, United States
- South Denver Cardiology Associates, PC — Denver, Colorado, United States
- Danbury Hospital — Danbury, Connecticut, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Bradenton Cardiology — Bradenton, Florida, United States
- Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
- Broward General Medical Center — Fort Lauderdale, Florida, United States
- Providence Alaska Medical Center — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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