Status:
RECRUITING
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
Lead Sponsor:
Vivek Reddy
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 20 clinical sites in the United States. Once the clinical sites are up and running (expect...
Eligibility Criteria
Inclusion
- 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.)
- History of hypertension and either:
- Documented history of SBP≥160 or DBP≥100, or;
- Receiving ≥1 antihypertensive medication;
- Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
Exclusion
- 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;
- Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography);
- Main renal artery diameter \<3mm or \>8.0 mm
- Main renal treatable artery length \< 20 mm (length may include proximal branches)
- Presence of renal artery stenosis of any origin ≥30%
- Calcification in renal arteries
- Prior renal denervation procedure
- Presence of abnormal kidney tumors
- Renal artery aneurysm
- Pre-existing renal stent or history of renal artery angioplasty
- Pre-existing aortic stent or history of aortic aneurysm
- Fibromuscular disease of the renal arteries
- Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
- Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation;
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Individual with known allergy to contrast medium not amendable to treatment.
- Life expectancy \<1 year for any medical condition
- Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit.
- Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
- Female participants who are pregnant or nursing.
- Individual has known secondary hypertension.
- Individual has a single functioning kidney (either congenitally or iatrogenically).
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this protocol.
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05988411
Start Date
December 7 2023
End Date
December 1 2027
Last Update
December 15 2025
Active Locations (8)
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1
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
2
UCSF
San Francisco, California, United States, 94143
3
Los Robles Medical Center
Thousand Oaks, California, United States, 91360
4
Henry Ford Health System
Detroit, Michigan, United States, 48202