Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

Conditions

• Atrial Fibrillation - Symptomatic

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Radiofrequency ablation — PROCEDURE
  Ablation procedure to eliminate atrial fibrillation

Study Details

A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a: 1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to , 2. an approach of pulmonary vein isolation (PVI) alone.

Key Dates

Start date

Jul 14, 2019

Status verified

Jun 2024

Primary completion

May 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pulmonary vein isolation (PVI) alone
  Radiofrequency ablation procedure to isolate pulmonary veins without other intervention performed..
• Active Comparator: PVI+Total LT Atrial low voltage ablation
  PVI radiofrequency ablation along with ablation of areas of "low voltage" identified.

Primary Outcome Measure

Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia. [ Time Frame: Any event between the 3 month blanking period and 1 year post-ablation. ]

Central Contacts

• Peter Leo BS, RN
  216-778-2714
  [email protected]

Locations (1)

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