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

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)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: No AAD post Ablation.

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1- No AAD post Ablation; Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation.	Other: No AAD post Ablation.; Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation; Other Names: No AAD
No Intervention: Arm 2-Resume AAD post Ablation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cost of AADs during the 90-day blanking period.	The cost of AADs during the 90-day blanking period.	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	12 months
The differential usage of anticoagulation therapy between two arms.	The differential usage of anticoagulation therapy between two arms.	12 months

Collaborators and Investigators

• Sponsor: Prisma Health-Midlands
• Collaborators: Medtronic
• Investigators: Principal Investigator: Sultan M Siddique, MD, Prisma Health-Midlands

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac Arrhythmias; Antiarrhythmic Agents; Catheter Ablation, electric; Anti-Arrhythmia Drugs
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: Pro00055684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No