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

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913014
• Other study ID #: Pro00055684
• Status: Completed
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Prisma Health-Midlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Other:
• No AAD post Ablation.
Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation

Locations

Country	Name	City	State
United States	Palmetto Health	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Midlands	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The cost of AADs during the 90-day blanking period.	The cost of AADs during the 90-day blanking period.	12 months
Secondary	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
Secondary	The differential usage of anticoagulation therapy between two arms.	The differential usage of anticoagulation therapy between two arms.	12 months