ARIADNE Clinical Trial

Part of paid clinical trials in Manhasset, New York.

Sponsor
Stavros E Mountantonakis
Study ID
NCT06747091
Status
Recruiting
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Conditions

  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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:

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: PVI using PFA energy
    Pulmonary vein isolation using PFA energy
  • Active Comparator: PVI and posterior wall isolation using PFA energy
    Pulmonary vein isolation and posterior wall isolation using PFA energy
  • Active Comparator: PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.
    Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.

Primary Outcome Measure

Percent of subjects free from primary effectiveness failure [ Time Frame: 12 Months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
North Shore University HospitalManhassetNew York11030
Salome Reddy
[email protected]
James Gabriels, MD (SUB_INVESTIGATOR)
Long Island Jewish Medical CenterNew Hyde ParkNew York11040
Charell Brinkley
[email protected]
Haisam Ismail, MD (SUB_INVESTIGATOR)
Kristie ColemanNew YorkNew York10075
Kristie Coleman, RN
[email protected]
212-434-6500
Stavros E Mountantonakis, MD (PRINCIPAL_INVESTIGATOR)

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