Combining renal denervation with pulmonary vein isolation for treating persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial evaluates the effectiveness of renal artery denervation (RDN) in addition to pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). The study aims to determine if this combined approach enhances long-term outcomes compared to PVI alone, particularly in patients with controlled hypertension. Participants will undergo catheter ablation and will have implantable loop recordings to monitor their heart rhythm over time. The trial builds on previous findings that suggest RDN may reduce recurrent AF by decreasing cardiac sympathetic stimulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 years
2. Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation \> 7 days and up to 1 year)
3. No prior history of HTN or HTN controlled on medical therapy (defined as SBP \<140 mm Hg and DBP \<85 mm Hg)
4. Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram
5. Willingness to undergo ILR placement
6. Willingness to comply with post-procedural follow-up requirements and to sign informed consent.

Exclusion Criteria:

1. Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
2. Prior left atrial ablation for an atrial arrhythmia
3. NYHA class IV congestive heart failure or LVEF \< 25%
4. Paroxysmal AF, or longstanding persistent AF (duration \> 1 year)
5. Coronary revascularization or valve surgery within 3 months
6. Prior valve surgery using a mechanical prosthesis
7. Renal artery anatomy that is ineligible for treatment including:

   1. Predicted inability to access renal vasculature
   2. Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
   3. Hemodynamically or anatomically significant renal artery abnormality or stenosis
   4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
   5. Multiple main renal arteries to either kidney
8. An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
9. Life expectancy \<1 year for any medical condition

Where it's running

• University of Rochester
  Short Hills, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Jonathan Steinberg, MD
• Email: jsteinberg@smgnj.com
• Phone: 9734364155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.