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NCT01635998 · ClinicalTrials.gov registry record · NA
Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
A NA study of Atrial Fibrillation and Uncontrolled Hypertension, sponsored by Vivek Reddy.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 8
- Study locations
NCT01635998: Completed NA study of Atrial Fibrillation and Uncontrolled Hypertension, sponsored by Vivek Reddy.
NCT01635998 is a NA study of Atrial Fibrillation and Uncontrolled Hypertension that has completed, run by Vivek Reddy. The registered enrollment target is 50 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01635998, a NA study of Atrial Fibrillation and Uncontrolled Hypertension, has completed, sponsored by Vivek Reddy.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 8
- Study locations
Study Summary
The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
Primary Outcome
The primary endpoint of this study is anti-arrhythmic drug (AAD)-free single-procedure freedom from AF recurrence through 12 months (not including a 90 day blanking period).
Conditions Studied
Interventions
- DEVICE Boston Scientific Vessix Renal Denervation System
Study Locations (8)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
Other
- Na Homolce Hospital - Prague
- Siberian Biomedical Research Center Ministry of Health Russian Federation - Novosibirsk
California
- Regional Cardiology Associates - Sacramento
Kansas
- University of Kansas Medical Center - Kansas City
New York
- Mount Sinai Hospital - New York
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-09-17 |
| Est. Completion | 2019-07-11 |
| Phase | NA |
What the finished NCT01635998 record still lists
NCT01635998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Boston Scientific Vessix Renal Denervation System is the first listed.
NCT01635998 lists 8 locations in 6 states (Massachusetts, Other, California).
Frequently Asked Questions
What is clinical trial NCT01635998 about?
NCT01635998 is a clinical study titled "Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation". The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (us...
What is the current status of trial NCT01635998?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2012-09-17. Estimated completion is 2019-07-11.
What conditions does trial NCT01635998 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Uncontrolled Hypertension.
What interventions are being tested in trial NCT01635998?
The interventions under investigation include: Boston Scientific Vessix Renal Denervation System (DEVICE).
Who is sponsoring clinical trial NCT01635998?
This trial is sponsored by Vivek Reddy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01635998 being conducted?
This trial has 8 study locations across California, Kansas, Massachusetts, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01635998's enrollment target sits among peer trials
50 174th of 202 higher than 25 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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.
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