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

Prisma Health-Midlands50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

No AAD post Ablation.OTHER

Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Palmetto Health

Columbia, South Carolina, United States

Outcomes

Primary Outcomes

Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups.

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

Time frame: 12 months

Symptom Assessments

Symptom assessments by clinical follow up and phone calls, including symptom severity score using the Severity of Atrial Fibrillation Scale between the two groups.

Time frame: 12 months

Adverse Events Assessments

Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period.

Time frame: 12 months

Secondary Outcomes

The cost of AADs during the 90-day blanking period.

Time frame: 12 months

Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups

A) Event during the 90-day blanking period will be assessed for AAD related and unrelated adverse events that caused the cardiac related visit

Time frame: 12 months

The differential usage of anticoagulation therapy between two arms.

Time frame: 12 months

Data from ClinicalTrials.gov

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