Longitudinal Surveillance Study of the 4-SITE Lead/Header System

NCT01596595 | Completed Results

• 1 other identifier: LSS of 4-SITE
• Study Type: observational
• Target: 1,820
• Locations: 3 countries
• Sites: 111

Brief Summary

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.

Conditions

Primary Prevention of Sudden Cardiac Arrest; Secondary Prevention of Sudden Cardiac Arrest

Keywords

ICD; CRT-D; Defibrillation lead

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years

  The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.

  5 years

Study Arms (1)

Medically Indicated for ICD or CRT-D

Medically Indicated for ICD or CRT-D implantation per guidelines

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From Physicians patient population

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (111)

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Cardiovascular Consultants, LTD

Glendale, Arizona, 85032, United States

Location

Cardiovascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85006, United States

Location

Heart Clinic Arkansas

Little Rock, Arkansas, 72205, United States

Location

Providence St. Joseph Medical Center

Burbank, California, 91505, United States

Location

Palomar Medical Center

Escondido, California, 92025, United States

Location

California Heart Associates

Fountain Valley, California, 92708, United States

Location

Luc Sinh Nguyen, MD, FACC, Inc.

Fountain Valley, California, 92708, United States

Location

Providence Holy Cross Medical Center

Los Angeles, California, 90024, United States

Location

Cardiac Device Rhythm Specialists

Los Angeles, California, 90033, United States

Location

Comprehensive Cardiovascular Medical Group

Los Angeles, California, 93309, United States

Location

Desert Regional Medical Center

Palm Springs, California, 62262, United States

Location

Truong D. Duong, MD. A Medical Corporation

Riverside, California, 92503, United States

Location

San Diego Arrhythmia Associates

San Diego, California, 92103, United States

Location

Good Samaritan Hospital - San Jose

San Jose, California, 95124, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

Little Company of Mary Hospital

Torrance, California, 90503, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

South Denver Cardiology Associates, PC

Denver, Colorado, 80120, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Bradenton Cardiology

Bradenton, Florida, 34205, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

First Coast Cardiovascular

Jacksonville, Florida, 32216, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32250, United States

Location

Osceola Regional Medical Center

Kissimmee, Florida, 34741, United States

Location

Cardiovascular Research Center of South Florida

Miami, Florida, 33173, United States

Location

Charlotte Heart & Vascular

Port Charlotte, Florida, 33952, United States

Location

Brevard Cardiovascular Research Associates, Inc.

Rockledge, Florida, 32955, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

Location

Northeast Georgia Heart Center

Gainesville, Georgia, 30501, United States

Location

Gwinnett Hospital System Inc.

Lawrenceville, Georgia, 30046, United States

Location

Georgia Arrhythmia Consultants

Macon, Georgia, 31201, United States

Location

Atlanta Heart Associates

Stockbridge, Georgia, 30281, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Illinois Heart and Vascular at Adventist Hinsdale Hospital

Hinsdale, Illinois, 60521, United States

Location

Heartland Cardiovascular Center

Joliet, Illinois, 60435, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Bloomington Hospital

Bloomington, Indiana, 47403, United States

Location

Parkview Memorial Hospital

Fort Wayne, Indiana, 46805, United States

Location

Mercy Hospital Medical Center

Des Moines, Iowa, 50314, United States

Location

The Iowa Clinic, PC

Des Moines, Iowa, 50314, United States

Location

Kansas City Heart Foundation

Kansas City, Kansas, 64114, United States

Location

Via-Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

MedStar Health Research Institute

Baltimore, Maryland, 21237, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Centracare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Cox Health

Springfield, Missouri, 65807, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Billings Clinic

Billings, Montana, 59107, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Cardiovascular Associates of the Delaware Valley

Sewell, New Jersey, 08080, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

SUNY-Stony Brook School of Medicine

Stony Brook, New York, 24421, United States

Location

Cardiology Group of West New York

Williamsville, New York, 14221, United States

Location

Universtity of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

The Toledo Hospital

Toledo, Ohio, 43615, United States

Location

Genesis Healthcare System

Zanesville, Ohio, 43701, United States

Location

Salem Hospital

Salem, Oregon, 97302, United States

Location

The Arrhythmia Institute

Newton, Pennsylvania, 18940, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, 19067, United States

Location

Southcoast Physicians Group

Providence, Rhode Island, 02904, United States

Location

Sisters of Charity Providence Hospital

Columbia, South Carolina, 29204, United States

Location

PeeDee Cardiology Associates PA

Florence, South Carolina, 29506, United States

Location

Piedmont Medical Center

Greenwood, South Carolina, 29646, United States

Location

Lexington Medical Center

Lexington, South Carolina, 29072, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospit

Rapid City, South Dakota, 57701, United States

Location

Saint Thomas Health

Nashville, Tennessee, 37205, United States

Location

Wellmont Holston Valley Medical Center

Rogersville, Tennessee, 37857, United States

Location

SouthEast Texas Clinical Research Center

Beaumont, Texas, 77702, United States

Location

Houston Arrhythmia Associates

Houston, Texas, 77024, United States

Location

Arrhythmia Associates of South Texas

San Antonio, Texas, 78217, United States

Location

Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23219, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

Bellin Health

Green Bay, Wisconsin, 54305, United States

Location

Meriter Hospital, Inc.

Madison, Wisconsin, 53713, United States

Location

Cheyenne Regional Medical Center

Cheyenne, Wyoming, 82001, United States

Location

Mount Hospital

Perth, Western Australia, 6000, Australia

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Fleurimont Hospital

Sherbrooke, Quebec, J1H5N4, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Ste Foy, Quebec, G1V 4G5, Canada

Location

Results Point of Contact

• Title: Paji Vitoff, Manager, Clinical Trials
• Organization: Boston Scientific

Paji.Vitoff@bsci.com

651-582-5415

Study Officials

• Stephen Kutalek, MD

  Drexel University, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 11, 2012
• Study Start: April 4, 2013
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: March 19, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

US (104); AU (1); CA (6)