CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Boston Scientific Vessix Renal Denervation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01635998
NCT01635998N/ACompleted

Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation

Vivek Reddy·interventional·Posted Jul 10, 2012·Updated Nov 5, 2020

In Brief

A clinical study evaluating Boston Scientific Vessix Renal Denervation System for Uncontrolled Hypertension and Atrial Fibrillation. Completed, enrolled 50 participants across 8 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Russia, United States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 10, 2012
Enrollment StartSep 17, 2012
Primary CompletionJul 11, 2019
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 14.0 years ago

Interventions

Boston Scientific Vessix Renal Denervation Systemdevice

Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts