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

Prisma Health-Midlands

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: No AAD post Ablation.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02913014

Pro00055684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm 1- No AAD post Ablation

Active Comparator group

Description:

Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation.

Treatment:

Other: No AAD post Ablation.

Arm 2-Resume AAD post Ablation

No Intervention group

Description:

Subjects will resume their pre-ablation Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation, during the 90 day blanking period following the ablation.