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

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Vivek Reddy
Study ID
NCT05988411
Status
Recruiting
Apply to this trial

Conditions

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Dec 7, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Catheter ablation + renal denervation
    Catheter ablation + renal denervation
  • Active Comparator: Catheter ablation only
    Catheter ablation

Primary Outcome Measure

Freedom from atrial arrhythmias with no AADs [ Time Frame: after 90 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Arrhythmia Research GroupJonesboroArkansas72401
Sarah Owens
[email protected]
870-336-8324
Devi Nair (PRINCIPAL_INVESTIGATOR)
UCSFSan FranciscoCalifornia94143
Marialena Varympopioti
[email protected]
415-514-7310
Edward Gerstenfeld (PRINCIPAL_INVESTIGATOR)
Los Robles Medical CenterThousand OaksCalifornia91360
Marya Bengali
[email protected]
805-796-2015
Andrea Natale (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Danielle Delmotte
[email protected]
313-916-1719
Marc Lahiri (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Jeff Lam, MS
[email protected]
212-824-8929
Betsy Ellsworth, MSN ANP
[email protected]
(212) 824-8902
Abhishek Maan (PRINCIPAL_INVESTIGATOR)
Trident Medical CenterCharlestonSouth Carolina29406
Molly Harper
[email protected]
843-973-2898
Frank Cuoco (PRINCIPAL_INVESTIGATOR)
ChristusTylerTexas75702
Adrian Maples
[email protected]
903-606-2412
Stanislav Weiner (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Caleb Bridgwater
[email protected]
804-628-8527
Jayathi Koneru (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jonesboro, AR

By research site
Arrhythmia Research Group· Jonesboro, ARUCSF· San Francisco, CALos Robles Medical Center· Thousand Oaks, CAHenry Ford Health System· Detroit, MIMount Sinai Hospital· New York, NYTrident Medical Center· Charleston, SC

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