RECRUITING

Renal Denervation + PVI vs PVI Alone for Persistent AF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives. This is a randomized controlled pilot trial, "To Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II) to test if RDN plus PVI enhances long-term efficacy vs PVI for persistent AF patients with controlled or without hypertension using implantable loop recordings.

Official Title

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

Quick Facts

Study Start:2023-07-30

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05116384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Jonathan Steinberg, MD

CONTACT

9734364155

jsteinberg@smgnj.com

Study Locations (Sites)

University of Rochester

Short Hills, New Jersey, 07078

United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-30

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-07-30

Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

Atrial Fibrillation