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

A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation

This study is testing if combining a new kidney treatment with a common heart procedure can help people with ongoing atrial fibrillation feel better and have fewer heart rhythm problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Rochester (other)
• Locations: 1 site (Short Hills, New Jersey)
• Trial ID: NCT05116384 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with symptomatic persistent atrial fibrillation who are eligible for PVI and have controlled hypertension.

Not a fit: Patients with paroxysmal atrial fibrillation or those with longstanding persistent AF may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved long-term outcomes for patients with persistent atrial fibrillation.

How similar studies have performed: Previous studies, such as the ERADICATE-AF trial, have shown promising results for similar approaches, indicating potential for success.

Eligibility criteria

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 this trial is running

Short Hills, New Jersey

• University of Rochester — Short Hills, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Jonathan Steinberg, MD

Conditions: Atrial Fibrillation