Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial
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- STATUS
- Recruiting
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- days left to enroll
- 59
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- participants needed
- 268
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- sponsor
- Institute for Clinical Effectiveness, Japan
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.
Details
| Condition | Cardiac ablation, Arrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, atrial fibrillation (pediatric), atrial fibrillation (pediatric), Pulmonary Vein Isolation, Posterior Wall Isolation |
|---|---|
| Age | 18years - 100years |
| Treatment | Pulmonary Vein Isolation, Left posterior wall isolation |
| Clinical Study Identifier | NCT04405258 |
| Sponsor | Institute for Clinical Effectiveness, Japan |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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