Actively Recruiting
Study Comparing Renal Artery Denervation Plus Catheter Ablation to Catheter Ablation Alone for Persistent Atrial Fibrillation in Adults
Led by University of Rochester · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding renal artery denervation RDN to pulmonary vein isolation PVI improves long-term outcomes for patients with persistent atrial fibrillation AF, including those with controlled or no hypertension. This randomized controlled pilot trial builds on prior findings that RDN plus PVI reduced AF recurrence in patients with uncontrolled hypertension. The study aims to test the antiarrhythmic benefits of combining these treatments using implantable loop recorders for detailed heart rhythm monitoring. The study compares two groups one receiving catheter ablation using cryoballoon energy to isolate pulmonary veins PVI alone and another receiving the same PVI procedure followed by radiofrequency renal artery denervation targeting both renal arteries. This approach seeks to reduce cardiac sympathetic stimulation, which may contribute to AF. The trial includes a single-blind design and uses implantable loop recorders to track AF burden over time. Participants will undergo the assigned procedures and then be followed for 12 months, with regular assessments including blood pressure monitoring, evaluation of cardiac sympathetic activity, safety checks, and quality of life questionnaires. Outcomes include measuring AF burden at one year, procedural complications, changes in blood pressure, progression to persistent AF, hospital visits, and overall quality of life. The trial will provide important data on the safety and potential benefits of adding RDN to standard PVI therapy.
CONDITIONS
Brief Title
Renal Denervation + PVI vs PVI Alone for Persistent AF
Research Team
J
Jonathan Steinberg, MD
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