ARIADNE Clinical Trial

NCT06747091 | Recruiting

• 1 other identifier: 24-0935-LHH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.

Conditions

Persistent Atrial Fibrillation

Keywords

Pulsed Field Ablation

Outcome Measures

Primary Outcomes (1)

• Percent of subjects free from primary effectiveness failure

  The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) lasting \>2 minutes based on electrocardiographic data through 12-month follow-up and excluding a 60-day blanking period.

  12 Months

Study Arms (3)

PVI using PFA energy

ACTIVE COMPARATOR

Pulmonary vein isolation using PFA energy

Procedure: Catheter Ablation

PVI and posterior wall isolation using PFA energy

ACTIVE COMPARATOR

Pulmonary vein isolation and posterior wall isolation using PFA energy

Procedure: Catheter Ablation

PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.

ACTIVE COMPARATOR

Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.

Procedure: Catheter Ablation

Interventions

Catheter Ablation PROCEDURE

This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:

PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.; PVI and posterior wall isolation using PFA energy; PVI using PFA energy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Symptomatic PerAF documented by
• (1a) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND electrocardiographic evidence
• \. . Suitable candidate for catheter ablation.
• \. . Adults aged 18 - 80 years.
• \. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

You may not qualify if:

• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
• Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
• Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• Any carotid stenting or endarterectomy.
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
• Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
• Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
• Documented left atrial thrombus on imaging.
• History of blood clotting or bleeding abnormalities.
• Any condition contraindicating chronic anticoagulation.
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• Body mass index \>40 kg/m2.
• Left atrial diameter \>55 mm (anterioposterior).
• Diagnosed atrial myxoma.

Sponsors & Collaborators

• Stavros E Mountantonakis: lead

Study Sites (3)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Kristie Coleman

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Stavros Mountantonakis, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristie Coleman, MPH, RN

CONTACT

2124346500; kcoleman1@Northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the ablation strategy they are randomized to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cardiac Electrophysiology

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 24, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (3)