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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 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.

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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.

Conditions Studied

Atrial Fibrillation Uncontrolled Hypertension

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

FieldValue
Enrollment Target 50 participants
Start Date 2012-09-17
Est. Completion 2019-07-11
Phase NA

Sponsor

Vivek Reddy

20 total trials

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What the Registry Record Tells You About NCT01635998

The ClinicalTrials.gov registry entry for NCT01635998 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The listed sponsor is Vivek Reddy, which has 20 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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, or report a data error.