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ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients

ConditionsParoxysmal Atrial FibrillationPersistent Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVivek Reddy

About this trial

This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18;

Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, 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). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)

Documented history of SBP≥160 or DBP≥100, or;

Receiving ≥1 antihypertensive medication;

Disqualifiers

Long-standing persistent AF (>12 months); >3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.

Individual with valvular AF or AF due to a reversible cause

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Renal Denervation

    Device

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

  • Catheter Ablation

    Device

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Catheter ablation + renal denervationExperimental treatment 2 interventions
Group B: Catheter ablation onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from atrial arrhythmias with no AADs

Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).

Time frame
after 90 days

Secondary outcomes

1

Freedom from atrial arrhythmias (AT/AF/AFL) with AADs

Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs

Time frame
at 12 months
2

Procedure-related adverse events

Number of procedure-related adverse events

Time frame
at 12 months
3

Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)

Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.

Time frame
at 12 months
4

Blood pressure

Blood pressure - Systolic and Diastolic

Time frame
at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vivek Reddy

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Source ClinicalTrials.gov
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