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NCT02071173 · ClinicalTrials.gov registry record · NA
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
A NA study of Cardiac Resynchronization Therapy, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 2,244
- Enrollment target
- 20
- Study locations
NCT02071173: Completed NA study of Cardiac Resynchronization Therapy, sponsored by Boston Scientific Corporation.
NCT02071173 is a NA study of Cardiac Resynchronization Therapy that has completed, run by Boston Scientific Corporation. The registered enrollment target is 2,244 participants, above the 180-participant average among 3 other Cardiac Resynchronization Therapy trials with a reported enrollment target (1147% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02071173, a NA study of Cardiac Resynchronization Therapy, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,244 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.
Primary Outcome
Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.
Conditions Studied
Interventions
- DEVICE ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
Study Locations (20)
California
- Kaiser Permanente - Los Angeles
- USC Medical Center - Los Angeles
- Alta Bates Medical Center - Oakland
- Mercy General Hospital - Sacramento
- Sharp Memorial Hospital - San Diego
Florida
- Delray Medical Center - Fort Lauderdale
- Lakeland Regional Medical Center - Lakeland
- West Florida Cardiology Network, LLC - Largo
- Tallahassee Memorial Hospital - Tallahassee
- Tampa General Hospital - Tampa
Alabama
- University of Alabama at Birmingham - Birmingham
- Huntsville Hospital - Huntsville
Arizona
- Banner Baywood Heart Hospital - Mesa
- Scottsdale Healthcare - Osborn - Scottsdale
Connecticut
- Hartford Hospital - Hartford
- Yale University School of Medicine - New Haven
Georgia
- Emory University Hospital - Atlanta
- Gwinnett Hospital System Inc. - Lawrenceville
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Cardiology Associates of Northeast Arkansas, P.A. - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,244 participants |
| Start Date | 2014-04-14 |
| Est. Completion | 2020-10-06 |
| Phase | NA |
What the finished NCT02071173 record still lists
NCT02071173 is an interventional study that assigns participants to a tested intervention. Its 2,244 participants enrollment target places it among the larger protocols in the corpus, above the 180-participant average among 3 other Cardiac Resynchronization Therapy trials with a reported enrollment target (1147% higher).
The record links to 1 condition, with Cardiac Resynchronization Therapy appearing as the primary indexed condition, and to 1 intervention - of which ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead is the first listed.
NCT02071173 names 20 study sites across 8 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02071173 about?
NCT02071173 is a clinical study titled "Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads". The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally,...
What is the current status of trial NCT02071173?
This trial is currently completed. It is a NA study. The enrollment target is 2,244 participants. The study started on 2014-04-14. Estimated completion is 2020-10-06.
What conditions does trial NCT02071173 study?
This clinical trial studies the following conditions: Cardiac Resynchronization Therapy.
What interventions are being tested in trial NCT02071173?
The interventions under investigation include: ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead (DEVICE).
Who is sponsoring clinical trial NCT02071173?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02071173 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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