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NCT02627196 · ClinicalTrials.gov registry record · NA
Baroreflex Activation Therapy for Heart Failure
A NA study, sponsored by CVRx.
- Completed
- Registry status
- NA
- Development phase
- 1,090
- Enrollment target
NCT02627196: Completed NA study, sponsored by CVRx.
NCT02627196 is a NA study that has completed, run by CVRx. The registered enrollment target is 1,090 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02627196, a NA study, has completed, sponsored by CVRx.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,090 participants
- Enrollment target
Study Summary
The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP\<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT). The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.
Primary Outcome
To demonstrate that treatment with the BAROSTIM NEO® System, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant. Event rates were calculated using negative binomial to account for varying follow-up times. Rates are expressed as events per patient-year, with 95% confidence intervals reflecting dispersion.
Interventions
- DRUG Medical Management
- DEVICE BAROSTIM NEO® System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,090 participants |
| Start Date | 2016-04-19 |
| Est. Completion | 2023-10 |
| Phase | NA |
What the finished NCT02627196 record still lists
NCT02627196 is an interventional study that assigns participants to a tested intervention. Its 1,090 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Medical Management is the first listed.
NCT02627196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02627196 about?
NCT02627196 is a clinical study titled "Baroreflex Activation Therapy for Heart Failure". The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejec...
What is the current status of trial NCT02627196?
This trial is currently completed. It is a NA study. The enrollment target is 1,090 participants. The study started on 2016-04-19. Estimated completion is 2023-10.
What interventions are being tested in trial NCT02627196?
The interventions under investigation include: Medical Management (DRUG), BAROSTIM NEO® System (DEVICE).
Who is sponsoring clinical trial NCT02627196?
This trial is sponsored by CVRx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02627196's enrollment target sits among peer trials
1,090 95th of 2000 higher than 1,906 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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