Clinical Outcomes of Persistent Atrial Fibrillation Ablation Using Ablation Index-guided Radiofrequency Catheter Ablation in Patients With Continuous Monitoring

Withdrawn

• Conditions: Persistent Atrial Fibrillation
• Interventions: Device: High-power, short-duration ablation using QDOT Micro catheter; Device: Ablation Index-guided ablation

• Registration Number: NCT05406310
• Lead Sponsor: St. Louis University

Brief Summary

Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart. Tablets to try to normalize the heart rhythm rarely work well. As a result, doctors have devised a treatment called catheter ablation in which special wires are used to deliver heat energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many patients (almost 1 in 2), some of these ablation lesions recover, and that leads to the recurrence of AF. Many of these patients then need a second procedure to deliver further ablation at these recovered areas.

Because of that problem, a software called Ablation Index has been developed to optimize the delivery of ablation lesions. The study aims to find out the effectiveness of the use of that Ablation Index in improving the ablation outcomes in patients with persistent AF. Also, the study will test the effectiveness of a new ablation approach using a catheter which is capable of delivering high-power during ablation and therefore requires shorter time for ablation. This will be achieved by following up patients who received ablation for 12 months to monitor their response to treatment in terms of freedom from AF.

This study will include patients with persistent AF which means AF episode(s) that last for longer than seven days. Patients participating in the study will undergo their ablation treatment either guided by ablation Index or delivered using high-power, short-duration (HPSD) ablation.

All participants will undergo implantation of a cardiac monitor, also knowns as loop recorder, to monitor for recurrence of atrial tachyarrhythmia following ablation. The monitor stores these ECG recordings which will be downloaded during review appointments that will be arranged 6 weeks, 3 months, 6 months and 12 months after the ablation procedure.

All participants will undergo implantation of a cardiac monitor, also knowns as a loop recorder, to monitor for recurrence of atrial tachyarrhythmia following ablation. The monitor stores these ECG recordings which will be downloaded during review appointments that will be arranged 6 weeks, 3 months, 6 months, and 12 months after the ablation procedure.

Detailed Description

Single-center, prospective cohort study including patients with persistent AF (PeAF).

Primary Hypothesis:

Single AF ablation procedure that includes PVI achieved with point-by-point Wide Area Circumferential catheter ablation (WACA) either guided by Ablation Index (AI) targets or by HPSD ablation delivered using QDOT Micro catheter results in reduction in ATA as detected by insertable cardiac monitor (ICM).

Secondary hypotheses:

Single AF ablation procedure that includes PVI achieved with point-by-point WACA guided by Ablation Index targets has low incidence of adverse events and results in freedom from ATA, and improvement of AF symptoms and quality of life.

AF ablation procedures done by HPSD ablation delivered using QDOT Micro catheter will have shorter time and similar outcomes to procedures done using SmartTouch SF catheter guided by Ablation Index targets.

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Study Start: 2024-05-01
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-power, short-duration ablation Group	High-power, short-duration ablation using QDOT Micro catheter	This is another prospective group of patients who will undergo persistent atrial fibrillation ablation by high-power, short-duration using QDOT Micro catheter.
Ablation-Index guided ablation group	Ablation Index-guided ablation	This is the prospective study group that will undergo persistent atrial fibrillation ablation guided by Ablation Index.

Primary Outcome Measures

Name	Time	Method
ICM-detected ATA burden	12 months	ICM-detected ATA burden measured as percentage of time spent in ATA (i.e., hours of ATA/hours of monitoring X 100)

Secondary Outcome Measures

Name	Time	Method
The occurrence of ATA recurrence of 2 minutes or more	12 month
QOL	6 and 12 months after initial ablation	QOL 6 and 12 months after initial ablation, as quantified by the validated AFEQT questionnaire.
Major complication rates	Within 60 days after a PVI procedure	Major complications include cardiac tamponade, stroke/TIA, myocardial infarction, phrenic nerve paralysis, oesophageal perforation/atrio-oesophageal fistula, major vascular complications, and death.