Clinical trial NCT02913014: Comparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy
Official title: Monitoring Safety and Recurrence of Paroxysmal Atrial Fibrillation After 1st Cryo-balloon Ablation with and Without Antiarrhythmic Drug Therapy During the 90-day Blanking Period - Examined with Adverse Event Monitoring and Cardiovascular Implantable Electronic Devices (CIEDs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Antiarrhythmic Agents
Catheter Ablation, electric
Cardiac Arrhythmias
Anti-Arrhythmia Drugs
Lead sponsor: Prisma Health-Midlands
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups.
timeFrame: 12 months
measure: Symptom Assessments
timeFrame: 12 months
measure: Adverse Events Assessments
timeFrame: 12 months
Secondary outcomes:
measure: The cost of AADs during the 90-day blanking period.
timeFrame: 12 months
measure: Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups
timeFrame: 12 months
measure: The differential usage of anticoagulation therapy between two arms.
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Palmetto Health
state: South Carolina
Study officials:
affiliation: Prisma Health-Midlands
name: Sultan M Siddique, MD
role: PRINCIPAL_INVESTIGATOR
References: