NCT04182620

Brief Summary

The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

13 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

November 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

4.6 years

First QC Date

November 27, 2019

Last Update Submit

May 6, 2025

Conditions

Atrial Fibrillation

Keywords

renal denervationatrial fibrillationcardiologyelectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds

    Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds off Class I and III AADs (after the 90-day blanking period), defined by absence of any electrocardiographically documented AT/AF.

    12 months

Secondary Outcomes (6)

  • Freedom from AT/AF/AFL recurrence

    12 months

  • Rate of procedural adverse events

    30 days

  • The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire

    12 months

  • Change in office systolic blood pressure change from baseline to 12 months

    12 months

  • AF burden at 6 months

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Catheter ablation + renal denervation

EXPERIMENTAL

Catheter ablation + renal denervation

Device: renal denervationDevice: Catheter ablation

Catheter ablation only

ACTIVE COMPARATOR

Catheter ablation

Device: Catheter ablation

Interventions

renal denervationDEVICE

Renal denervation using the Paradise renal denervation system - a dedicated RDN catheter that delivers a circumferential ring of ablative ultrasound energy

Catheter ablation + renal denervation
Catheter ablationDEVICE

Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation

Catheter ablation + renal denervationCatheter ablation only

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18
  • Planned for a first-ever AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as involving pulmonary vein isolation, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation must have been completed)
  • History of hypertension and either:
  • Documented history of SBP ≥ 160 or DBP ≥ 100 (Stage III), or
  • Receiving ≥ 1 antihypertensive medication
  • Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

You may not qualify if:

  • (if any of the following are YES, subject is not eligible)
  • Long-standing persistent AF (\> 12 months)
  • Individual with valvular AF or AF due to a reversible cause
  • Prior left atrial catheter or surgical ablation for an atrial arrhythmia (before this index procedure)
  • Prior left atrial surgery (such as mitral valve surgery or surgical ASD repair)
  • Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent and/or the CVRx barostimulator device
  • NYHA Class IV Congestive Heart Failure
  • Individual has renal artery anatomy that is ineligible for treatment (as determined by intra-procedural renal angiography). This includes:
  • Main renal artery diameter \< 3.0 mm or \> 8.0 mm
  • Main renal artery length \< 20 mm
  • Presence of renal artery stenosis of any origin ≥ 30%
  • Accessory arteries with diameter ≥ 2 mm and \< 3.0 mm
  • Calcification in renal arteries at locations where energy is to be delivered
  • Prior renal denervation procedure
  • Presence of abnormal kidney tumors
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Arizona - Banner University Medical Center

Phoenix, Arizona, 85004, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85016, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Loma Linda University Medical

Loma Linda, California, 92354, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Hartford Healthcare

Hartford, Connecticut, 06106, United States

Location

Naples Community Hospital

Naples, Florida, 34102, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Bellin Memorial Hospital Inc.

Green Bay, Wisconsin, 54305, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Vivek Reddy, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients will be blinded until the 6 month visit, at which time they will be un-blinded prior to the follow up CT/MRI. The Clinical Events Committee and Echo Core Lab will remain blinded throughout the trial. In general, the CEC will be blinded to the treatment arms. However, once the nature of the event has been adjudicated, the blind will be broken for that individual patient as necessary to enable the CEC to determine relatedness to the study device.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 2, 2019

Study Start

July 8, 2020

Primary Completion

February 26, 2025

Study Completion

February 26, 2025

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(13)