Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial (LEAP-AF)

Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation

The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).

Study Overview

• Status: Recruiting
• Conditions: Persistent Atrial Fibrillation; Catheter Ablation; Pulmonary Vein Isolation; Posterior Wall Isolation
• Intervention / Treatment: Procedure: Pulmonary vein isolation; Procedure: Left posterior wall isolation

Detailed Description

PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.

• Study Type: Interventional
• Enrollment (Anticipated): 268
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Keisuke Okawa, MD; Phone Number: 5555 +81-87-811-3333; Email: k-ookawa@chp-kagawa.jp
• Study Contact Backup: Name: Masahiko Takahashi, MD; Phone Number: 5558 +81-87-811-3333; Email: ma-takahashi@chp-kagawa.jp

Study Locations

• Japan
  • Kagawa
    • Takamatsu, Kagawa, Japan, 760-8557
      • Recruiting
      • Kagawa Prefectural Central Hospital
      • Contact: Keisuke Okawa, MD; Phone Number: 5555 +81-87-811-3333; Email: k-ookawa@chp-kagawa.jp
      • Contact: Masahiko Takahashi, MD; Phone Number: 5558 +81-87-811-3333; Email: ma-takahashi@chp-kagawa.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for first catheter ablation of persistent atrial fibrillation
• Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
• Patients with persisting duration of atrial fibrillation less than 3 years
• Patients with left atrial diameter less than 50mm
• Patients who can be followed up for 18 months
• Patients with written informed consent

Exclusion Criteria:

• Patients who can not be received adequate anticoagulation therapy
• Patients with history of myocardial infarction within 6 months
• Patients with history of open heart surgery
• Patients scheduled for open heart surgery
• Patients with severe valvular heart disease
• Patients during pregnancy
• Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
• Patients considered unsuitable for study by the attending physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PVI alone; Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation	Procedure: Pulmonary vein isolation; Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
Active Comparator: PVI and PWI; Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation	Procedure: Left posterior wall isolation; Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation	Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation	Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.	18 months
Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation	Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.	90 days
Repeated ablation of atrial tachyarrhythmia		18 months
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation		18 months
Atrial Fibrillation Quality of Life Questionnaire	Atrial Fibrillation Quality of Life Questionnaire	18 months
Complications of ablation procedure	Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury	1 month

Collaborators and Investigators

• Sponsor: Institute for Clinical Effectiveness, Japan
• Investigators: Principal Investigator: Keisuke Okawa, MD, Kagawa Prefectural Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 23, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Catheter ablation; Pulmonary vein isolation; Persistent atrial fibrillation; Posterior wall isolation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study will be available from the data center upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No