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

NCT05406310 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-07-15

No results posted yet for this study

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.

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Ablation Index-guided ablation

Radiofrequency catheter ablation guided by Ablation Index software.

DEVICE

High-power, short-duration ablation using QDOT Micro catheter

Radiofrequency catheter ablation guided by high-power, short-duration ablation using QDOT Micro catheter

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-06-30
Completion
2025-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406310 on ClinicalTrials.gov