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

NCT05406310 | Withdrawn DMC FDA Device

• 1 other identifier: 32462
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Persistent Atrial Fibrillation

Keywords

Ablation; Ablation Index; Loop Recorder; Recurrence

Outcome Measures

Primary Outcomes (1)

• ICM-detected ATA burden

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

  12 months

Secondary Outcomes (3)

• The occurrence of ATA recurrence of 2 minutes or more

  12 month

• QOL

  6 and 12 months after initial ablation

• Major complication rates

  Within 60 days after a PVI procedure

Study Arms (2)

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

High-power, short-duration ablation Group

This is another prospective group of patients who will undergo persistent atrial fibrillation ablation by high-power, short-duration using QDOT Micro catheter.

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

Interventions

Ablation Index-guided ablation DEVICE

Radiofrequency catheter ablation guided by Ablation Index software.

Ablation-Index guided ablation group

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

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

High-power, short-duration ablation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persistent atrial fibrillation patients who are 18 years or older and are indicated for atrial fibrillation ablation and have no exclusion criteria as listed above.

You may qualify if:

• Aged over 18 years
• 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)
• Symptomatic despite drug treatment.
• Due to undergo AF ablation.

You may not qualify if:

• Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA) or non-VKA (NOAC) agent
• Previous catheter or surgical ablation procedure for AF
• Unwillingness or inability to complete the required follow-up arrangements
• Current pattern of paroxysmal AF
• Long standing persistent AF (continuous AF longer than 12 months before ablation)
• Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
• Known infiltrative cardiomyopathy
• Known severe left ventricular systolic function (ejection fraction \<35%)
• Pregnancy

Sponsors & Collaborators

• St. Louis University: lead

Related Publications (2)

• 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.

  PMID: 30354288 BACKGROUND

• 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.

  PMID: 28639728 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: May 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07