AF-FAIR-MONTOR: Clinical Outcomes of Persistent Atrial Fibrillation Ablation Using Ablation Index-guided Radiofrequency Catheter Ablation in Patients With Continuous Monitoring
Study Details
Study Description
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. 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 guided by ablation Index.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Single-center, prospective cohort study including patients with persistent AF (PeAF).
Endpoints
Primary outcome measure:
Intracardiac monitor detected ATA burden measured as percentage of time spent in atrial tachyarrhythmia (ATA )(i.e., hours of ATA/hours of monitoring X 100)
Secondary outcome measures:
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The occurrence of ATA recurrence of 2 minutes or more during the 12 months following ablation (after an initial 3-month blanking period).
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Quality of life (QOL) 6 and 12 months after initial ablation, as quantified by the validated AFEQT questionnaire.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ablation-Index guided ablation group This is the prospective study group that will undergo persistent atrial fibrillation ablation guided by Ablation Index. |
Device: Ablation Index-guided ablation
Radiofrequency catheter ablation which is guided by Ablation Index software.
|
| Conventional Ablation Group This is a historical group of patients from previous studies who underwent persistent atrial fibrillation ablation by the conventional method using contact force-sensing catheters. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion criteria:
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Aged over 18 years
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Persistent AF defined according to the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, as AF episode that lasts longer than 7 days. (Calkins et al., 2017)
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Symptomatic despite drug treatment.
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Due to undergo AF ablation.
Exclusion criteria:
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Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA) or non-VKA (NOAC) agent
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Previous catheter or surgical ablation procedure for AF
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Unwillingness or inability to complete the required follow-up arrangements
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Current pattern of paroxysmal AF
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Long standing persistent AF (continuous AF longer than 12 months before ablation)
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Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
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Known infiltrative cardiomyopathy
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Known severe left ventricular systolic function (ejection fraction <35%)
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Pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- St. Louis University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Hussein A, Das M, Chaturvedi V, Asfour IK, Daryanani N, Morgan M, Ronayne C, Shaw M, Snowdon R, Gupta D. Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2017 Sep;28(9):1037-1047. doi: 10.1111/jce.13281. Epub 2017 Jul 26.
- Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.
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