Clinical trial NCT04405258: Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial
Official title: Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Persistent Atrial Fibrillation
Catheter Ablation
Pulmonary Vein Isolation
Posterior Wall Isolation
Keywords: Persistent atrial fibrillation
Catheter ablation
Pulmonary vein isolation
Posterior wall isolation
Lead sponsor: Institute for Clinical Effectiveness, Japan
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation
timeFrame: 18 months
Secondary outcomes:
measure: Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation
timeFrame: 18 months
measure: Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation
timeFrame: 90 days
measure: Repeated ablation of atrial tachyarrhythmia
timeFrame: 18 months
measure: Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation
timeFrame: 18 months
measure: Atrial Fibrillation Quality of Life Questionnaire
timeFrame: 18 months
measure: Complications of ablation procedure
timeFrame: 1 month
Other outcomes:
Locations:
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
Study officials:
affiliation: Kagawa Prefectural Central Hospital
name: Keisuke Okawa, MD
role: PRINCIPAL_INVESTIGATOR
References: