A Phase 4 interventional study of Pulmonary vein isolation and Left posterior wall isolation in Persistent Atrial Fibrillation, Catheter Ablation and Pulmonary Vein Isolation, sponsored by Institute for Clinical Effectiveness, Japan. Active, not recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Institute for Clinical Effectiveness, Japan · Phase 4, Interventional, and Treatment
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).
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 276 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Institute for Clinical Effectiveness, Japan is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
Procedure: Pulmonary vein isolation
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, and cavotricuspid isthmus ablation
Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation
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.
Time frame: 18 months
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.
Time frame: 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.
Time frame: 90 days
Repeated ablation of atrial tachyarrhythmia
Time frame: 18 months
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation
Time frame: 18 months
Atrial Fibrillation Quality of Life Questionnaire
Atrial Fibrillation Quality of Life Questionnaire
Time frame: 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
Time frame: 1 month
Plan to share: No — The data that support the findings of this study will be available from the data center upon reasonable request.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Institute for Clinical Effectiveness, Japan