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NCT04502316 · ClinicalTrials.gov registry record
Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)
A clinical trial of Heart Failure, sponsored by CVRx.
- Active
- Registry status
- 5,000
- Enrollment target
- 20
- Study locations
NCT04502316: Active study of Heart Failure, sponsored by CVRx.
NCT04502316 is a study of Heart Failure that is active but no longer recruiting, run by CVRx. The registered enrollment target is 5,000 participants, above the 2,036-participant average among 397 other Heart Failure trials with a reported enrollment target (146% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04502316, a study of Heart Failure, is active but no longer recruiting, sponsored by CVRx.
- ACTIVE NOT RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
Conditions Studied
Interventions
- DEVICE Barostim™ System
Study Locations (20)
Florida
- Orlando Cardiac & Vascular Specialists - Altamonte Springs
- Orlando Heart and Vascular Institute - Altamonte Springs
- Lakewood Cardiovascular - Bradenton
- AMA Heart and Vascular - Bradenton
- Cardiovascular Solutions Institute - Bradenton
- Cardiac Care Group - Cape Coral
- Daytona Heart Group - Daytona Beach
- Florida Heart Rhythm Specialists - Fort Lauderdale
- First Coast Cardiovascular Institute - Jacksonville
- Premier Cardiology & Vascular Associates - Maitland
- University of Miami - Miami
Arizona
- Chan Heart Rhythm Institute - Mesa
- Akil Loli Consulting LLC - Phoenix
California
- Cabrillo Cardiology Research Group - Oxnard
- COR Healthcare Medical Associates - Torrance
Colorado
- Aurora Denver Cardiology Associates - Aurora
- South Denver Cardiology Associates, P.C. - Littleton
District of Columbia
- Medstar Health Research Insitutute - Washington D.C.
- The George Washington University Medical Faculty Associates - Washington D.C.
Alabama
- Grandview Medical Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2028-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04502316
The ClinicalTrials.gov registry entry for NCT04502316 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,036-participant average among 397 other Heart Failure trials with a reported enrollment target (146% higher). The listed sponsor is CVRx, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Barostim™ System is the first listed.
NCT04502316 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04502316 about?
NCT04502316 is a clinical study titled "Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)". The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
What is the current status of trial NCT04502316?
This trial is currently active not recruiting. The enrollment target is 5,000 participants. The study started on 2020-06-26. Estimated completion is 2028-06.
What conditions does trial NCT04502316 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT04502316?
The interventions under investigation include: Barostim™ System (DEVICE).
Who is sponsoring clinical trial NCT04502316?
This trial is sponsored by CVRx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04502316 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.