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

• Sponsor: Prisma Health-Midlands (Other)
• Overall Status: Completed
• CT.gov ID: NCT02913014
• Collaborator: Medtronic (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 42.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Other: No AAD post Ablation.	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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)
• Actual Study Start Date: Jun 28, 2017
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

3. 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.

Secondary Outcome Measures

1. The cost of AADs during the 90-day blanking period. [12 months]

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

2. 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

3. The differential usage of anticoagulation therapy between two arms. [12 months]

   The differential usage of anticoagulation therapy between two arms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palmetto Health	Columbia	South Carolina	United States	29203

Sponsors and Collaborators

• Prisma Health-Midlands
• Medtronic

Investigators

• Principal Investigator: Sultan M Siddique, MD, Prisma Health-Midlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prisma Health-Midlands
• ClinicalTrials.gov Identifier: NCT02913014
• Other Study ID Numbers: Pro00055684
• First Posted: Sep 23, 2016
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prisma Health-Midlands: Antiarrhythmic Agents; Catheter Ablation, electric; Cardiac Arrhythmias; Anti-Arrhythmia Drugs
• Additional relevant MeSH terms: Atrial Fibrillation; Recurrence

Study Results

No Results Posted as of Mar 17, 2021