Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED NA

Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation

NCT01635998 · View on ClinicalTrials.gov ↗

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.

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

32 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01635998

The ClinicalTrials.gov registry entry for NCT01635998 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vivek Reddy, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01635998 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01635998?

The interventions under investigation include: Boston Scientific Vessix Renal Denervation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01635998?

This trial is sponsored by Vivek Reddy, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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