ClinicalTrials.gov record
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
ClinicalTrials.gov ID: NCT01596595
Public ClinicalTrials.gov record NCT01596595. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01596595
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,820 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 4, 2013 (Actual)
- Primary completion
- Feb 18, 2020 (Actual)
- Completion
- Feb 18, 2020 (Actual)
- Last update posted
- Mar 19, 2021
2013 – 2020
United States locations
- U.S. sites
- 104
- U.S. states
- 37
- U.S. cities
- 97
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Cardiovascular Consultants, LTD | Glendale | Arizona | 85032 | — |
| Cardiovascular Associates of Mesa | Mesa | Arizona | 85206 | — |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85006 | — |
| Heart Clinic Arkansas | Little Rock | Arkansas | 72205 | — |
| Providence St. Joseph Medical Center | Burbank | California | 91505 | — |
| Palomar Medical Center | Escondido | California | 92025 | — |
| California Heart Associates | Fountain Valley | California | 92708 | — |
| Luc Sinh Nguyen, MD, FACC, Inc. | Fountain Valley | California | 92708 | — |
| Providence Holy Cross Medical Center | Los Angeles | California | 90024 | — |
| Cardiac Device Rhythm Specialists | Los Angeles | California | 90033 | — |
| Comprehensive Cardiovascular Medical Group | Los Angeles | California | 93309 | — |
| Desert Regional Medical Center | Palm Springs | California | 62262 | — |
| Truong D. Duong, MD. A Medical Corporation | Riverside | California | 92503 | — |
| San Diego Arrhythmia Associates | San Diego | California | 92103 | — |
| Good Samaritan Hospital - San Jose | San Jose | California | 95124 | — |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93102 | — |
| Little Company of Mary Hospital | Torrance | California | 90503 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| South Denver Cardiology Associates, PC | Denver | Colorado | 80120 | — |
| Danbury Hospital | Danbury | Connecticut | 06810 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| Bradenton Cardiology | Bradenton | Florida | 34205 | — |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | — |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | — |
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | — |
| First Coast Cardiovascular | Jacksonville | Florida | 32216 | — |
| Baptist Medical Center | Jacksonville | Florida | 32250 | — |
| Osceola Regional Medical Center | Kissimmee | Florida | 34741 | — |
| Cardiovascular Research Center of South Florida | Miami | Florida | 33173 | — |
| Charlotte Heart & Vascular | Port Charlotte | Florida | 33952 | — |
| Brevard Cardiovascular Research Associates, Inc. | Rockledge | Florida | 32955 | — |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | — |
| Northeast Georgia Heart Center | Gainesville | Georgia | 30501 | — |
| Gwinnett Hospital System Inc. | Lawrenceville | Georgia | 30046 | — |
| Georgia Arrhythmia Consultants | Macon | Georgia | 31201 | — |
| Atlanta Heart Associates | Stockbridge | Georgia | 30281 | — |
| University of Chicago Hospital | Chicago | Illinois | 60637 | — |
| Illinois Heart and Vascular at Adventist Hinsdale Hospital | Hinsdale | Illinois | 60521 | — |
| Heartland Cardiovascular Center | Joliet | Illinois | 60435 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| Bloomington Hospital | Bloomington | Indiana | 47403 | — |
| Parkview Memorial Hospital | Fort Wayne | Indiana | 46805 | — |
| Mercy Hospital Medical Center | Des Moines | Iowa | 50314 | — |
| The Iowa Clinic, PC | Des Moines | Iowa | 50314 | — |
| Kansas City Heart Foundation | Kansas City | Kansas | 64114 | — |
| Via-Christi Regional Medical Center | Wichita | Kansas | 67214 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| University of Maryland Medical System | Baltimore | Maryland | 21201 | — |
| MedStar Health Research Institute | Baltimore | Maryland | 21237 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| Covenant Medical Center | Saginaw | Michigan | 48602 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| Centracare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| Cox Health | Springfield | Missouri | 65807 | — |
| St. Louis University Hospital | St Louis | Missouri | 63104 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Billings Clinic | Billings | Montana | 59107 | — |
| St. Patrick Hospital | Missoula | Montana | 59802 | — |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | — |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | — |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | — |
| Cardiovascular Associates of the Delaware Valley | Sewell | New Jersey | 08080 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Rochester General Hospital | Rochester | New York | 14621 | — |
| SUNY-Stony Brook School of Medicine | Stony Brook | New York | 24421 | — |
| Cardiology Group of West New York | Williamsville | New York | 14221 | — |
| Universtity of Cincinnati | Cincinnati | Ohio | 45267 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| The Toledo Hospital | Toledo | Ohio | 43615 | — |
| Genesis Healthcare System | Zanesville | Ohio | 43701 | — |
| Salem Hospital | Salem | Oregon | 97302 | — |
| The Arrhythmia Institute | Newton | Pennsylvania | 18940 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | — |
| Southcoast Physicians Group | Providence | Rhode Island | 02904 | — |
| Sisters of Charity Providence Hospital | Columbia | South Carolina | 29204 | — |
| PeeDee Cardiology Associates PA | Florence | South Carolina | 29506 | — |
| Piedmont Medical Center | Greenwood | South Carolina | 29646 | — |
| Lexington Medical Center | Lexington | South Carolina | 29072 | — |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | — |
| Rapid City Regional Hospit | Rapid City | South Dakota | 57701 | — |
| Saint Thomas Health | Nashville | Tennessee | 37205 | — |
| Wellmont Holston Valley Medical Center | Rogersville | Tennessee | 37857 | — |
| SouthEast Texas Clinical Research Center | Beaumont | Texas | 77702 | — |
| Houston Arrhythmia Associates | Houston | Texas | 77024 | — |
| Arrhythmia Associates of South Texas | San Antonio | Texas | 78217 | — |
| Trinity Mother Frances Health System | Tyler | Texas | 75701 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Utah Hospital and Clinics | Salt Lake City | Utah | 84132 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23219 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | — |
| Monongalia General Hospital | Morgantown | West Virginia | 26505 | — |
| Bellin Health | Green Bay | Wisconsin | 54305 | — |
| Meriter Hospital, Inc. | Madison | Wisconsin | 53713 | — |
| Cheyenne Regional Medical Center | Cheyenne | Wyoming | 82001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01596595, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2021 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01596595 live on ClinicalTrials.gov.