Comparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: No AAD post Ablation.

• Registration Number: NCT02913014
• Lead Sponsor: Prisma Health-Midlands

Brief Summary

This study is being done to find out if patients taking Anti Arrhythmia Drugs (AADs) after cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti- Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study will also look at the side effects of the AADs.

Detailed Description

Pulmonary vein isolation (PVI) is a cornerstone ablation strategy used in the management of paroxysmal atrial fibrillation (PAF), and it is a class IA indication for anti-arrhythmic drug (AAD) refractory symptomatic PAF. However, the consensus statements are vague about the utility of AAD management during the 90-day blanking window post-PVI. Moreover, there is no specific guidance to cryoballoon users on the usage of AADs during the 90-day blanking period that exists anywhere in the published literature. Simply, these studies have not been conducted with the cryoballoon procedure.

Study Timeline

• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-23
• Study Start: 2017-06-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Drug refractory and recurrent Paroxysmal Atrial Fibrillation
• The subject meets medical criteria for cryoballoon ablation to treat Paroxysmal AF
• Age 18 to 80 years
• The subject has a Cardiovascular Implantable Electronic Device (CIED) that captures AF episodes, such as an implantable loop recorder, pacemaker, or implantable cardioverter defibrillator (ICD) with a properly functioning atrial lead.

Exclusion Criteria

• Use of any Anti- Arrhythmic Drugs for ventricular arrhythmias
• Ejection Fraction (EF)<45%
• Prior A. Fib. ablation
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1- No AAD post Ablation	No AAD post Ablation.	Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation.

Primary Outcome Measures

Name	Time	Method
Symptom Assessments	12 months	Symptom assessments by clinical follow up and phone calls, including symptom severity score using the Severity of Atrial Fibrillation Scale between the two groups.
Adverse Events Assessments	12 months	Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period.
Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups.	12 months	Rhythm status through implantable loop recorder (or pacemaker with functioning atrial lead) at 3 month, 6 month, 12 month compared between two treatment groups, including: A) AF burden (Average amount of time in AF per day) B) AF recurrence rate (Frequency of AF, occurrences per day) C) Time to AF recurrence

Secondary Outcome Measures

Name	Time	Method
The cost of AADs during the 90-day blanking period.	12 months	The cost of AADs during the 90-day blanking period.
Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups	12 months	A) Event during the 90-day blanking period will be assessed for AAD related and unrelated adverse events that caused the cardiac related visit
The differential usage of anticoagulation therapy between two arms.	12 months	The differential usage of anticoagulation therapy between two arms.

Trial Locations

Locations (1)

Palmetto Health; 🇺🇸 Columbia, South Carolina, United States