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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04405258
Other study ID # 947
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date June 8, 2020
Est. completion date June 30, 2026

Study information

Verified date June 2024
Source Institute for Clinical Effectiveness, Japan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 276
Est. completion date June 30, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Japan Kagawa Prefectural Central Hospital Takamatsu Kagawa

Sponsors (1)

Lead Sponsor Collaborator
Institute for Clinical Effectiveness, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Repeated ablation of atrial tachyarrhythmia 18 months
Secondary Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation 18 months
Secondary Atrial Fibrillation Quality of Life Questionnaire Atrial Fibrillation Quality of Life Questionnaire 18 months
Secondary 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
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