Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

NCT04405258 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 947
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Persistent Atrial Fibrillation; Catheter Ablation; Pulmonary Vein Isolation; Posterior Wall Isolation

Keywords

Persistent atrial fibrillation; Catheter ablation; Pulmonary vein isolation; Posterior wall isolation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation

  18 months

• Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation

  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

  18 months

Study Arms (2)

PVI alone

ACTIVE COMPARATOR

Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation

Procedure: Pulmonary vein isolation

PVI and PWI

ACTIVE COMPARATOR

Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation

Procedure: Left posterior wall isolation

Interventions

Pulmonary vein isolation PROCEDURE

Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation

PVI alone

Left posterior wall isolation PROCEDURE

Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation

PVI and PWI

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical Effectiveness, Japan: lead

Study Sites (1)

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, 760-8557, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Keisuke Okawa, MD

  Kagawa Prefectural Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: June 8, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)