NCT01635998

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 17, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

6.8 years

First QC Date

July 5, 2012

Results QC Date

September 3, 2020

Last Update Submit

October 15, 2020

Conditions

Uncontrolled HypertensionAtrial Fibrillation

Keywords

renal sympathetic denervationrenal catheter ablationhypertension

Outcome Measures

Primary Outcomes (1)

  • Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence

    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).

    up to 12 months

Secondary Outcomes (10)

  • AAD-free Single-procedure Freedom From AF Recurrence

    up to 24 months

  • Freedom From AF Recurrence Despite Taking AADs

    up to 24 months

  • Blood Pressure Control as Compared to Baseline

    baseline, 6 months, 12 months, and 24 months

  • Number of Participants With Major Adverse Cardiac Events (MACE)

    within 12 months of randomization

  • Number of Participants With Serious Adverse Events (SAE)

    up to 24 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

These subjects will undergo routine catheter ablation of atrial fibrillation PLUS renal sympathetic denervation with the Boston Scientific Vessix Renal Denervation System.

Device: Boston Scientific Vessix Renal Denervation System

Control arm

NO INTERVENTION

These subjects will undergo routine catheter ablation of atrial fibrillation only.

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

Also known as: renal denervation, denervation
Intervention arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years of age
  • History of AF (paroxysmal or persistent) and planned for a guideline-supported catheter ablation procedure
  • History of significant hypertension (defined as SBP ≥160 mm Hg and/or DBP ≥100 mmHg) and receiving treatment with at least one anti-hypertensive medication OR Clinical History of hypertension and receiving treatment with at least two anti-hypertensive medications (specifically for blood pressure reduction).
  • Renal vasculature is accessible as determined by intra-procedural renal angiography.
  • Ability to understand the requirements of the study
  • Willingness to adhere to study restrictions, comply with all post-procedural follow-up requirements and to sign informed consent

You may not qualify if:

  • Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
  • Prior left atrial ablation for an atrial arrhythmia (before this index procedure)
  • Patients with NYHA class IV congestive heart failure
  • Individual has known secondary hypertension
  • Individual has renal artery anatomy that is ineligible for treatment including:
  • Inability to access renal vasculature
  • Main renal arteries \< 3 mm in diameter or \< 20 mm in length.
  • Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
  • A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment.
  • Individual has an estimated glomerular filtration rate (eGFR) of less than 45mL/min/1.73m2, using the MDRD calculation.
  • Individual has a single functioning kidney (either congenitally or iatrogenically).
  • Individual is pregnant or nursing.
  • Life expectancy \<1 year for any medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Siberian Biomedical Research Center Ministry of Health Russian Federation

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Atrial FibrillationHypertension

Interventions

Denervation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Sam Cammack
Organization
Icahn School of Medicine at Mount Sinai
sam.cammack@mountsinai.org
(212) 824-8931

Study Officials

  • Vivek Reddy, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Cardiac Arrhythmia Service, Professor of Medicine

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

September 17, 2012

Primary Completion

July 11, 2019

Study Completion

July 11, 2019

Last Updated

November 5, 2020

Results First Posted

November 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(6)CZ(1)RU(1)