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Compares treatment options for Paroxysmal Atrial Fibrillation
Official title ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
ClinicalTrials.gov ID: NCT05988411
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18;
- Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined...
- History of hypertension and either:
- Documented history of SBP≥160 or DBP≥100, or;
- Receiving ≥1 antihypertensive medication;
You likely can't join if
- Long-standing persistent AF (\>12 months); \>3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive...
- 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 \ 8.0 mm
See the full eligibility criteria
- 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...
- 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
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- San Francisco, California, United States
- Thousand Oaks, California, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Charleston, South Carolina, United States
- Tyler, Texas, United States
- Richmond, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; San Francisco, California, United States; Thousand Oaks, California, United States; Detroit, Michigan, United States; New York, New York, United States; Charleston, South Carolina, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.