Back to resultsComparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No AAD post Ablation.
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring Antiarrhythmic Agents, Catheter Ablation, electric, Cardiac Arrhythmias, Anti-Arrhythmia Drugs
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
Sites / Locations
- Palmetto Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Arm 1- No AAD post Ablation
Arm 2-Resume AAD post Ablation
Arm Description
Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation.
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.
Outcomes
Primary Outcome Measures
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
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.
Adverse Events Assessments
Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period.
Secondary Outcome Measures
The cost of AADs during the 90-day blanking period.
The cost of AADs during the 90-day blanking period.
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
The differential usage of anticoagulation therapy between two arms.
The differential usage of anticoagulation therapy between two arms.
Full Information
NCT ID
NCT02913014
First Posted
August 31, 2016
Last Updated
March 15, 2021
Sponsor
Prisma Health-Midlands
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02913014
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Midlands
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Antiarrhythmic Agents, Catheter Ablation, electric, Cardiac Arrhythmias, Anti-Arrhythmia Drugs
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1- No AAD post Ablation
Arm Type
Active Comparator
Arm Description
Subjects will not resume their Anti Arrhythmic Drugs after cryoballoon-ablation for paroxysmal atrial fibrillation.
Arm Title
Arm 2-Resume AAD post Ablation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
No AAD post Ablation.
Other Intervention Name(s)
No AAD
Intervention Description
Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation
Primary Outcome Measure Information:
Title
Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups.
Description
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
Title
Symptom Assessments
Description
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
Title
Adverse Events Assessments
Description
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 Outcome Measure Information:
Title
The cost of AADs during the 90-day blanking period.
Description
The cost of AADs during the 90-day blanking period.
Time Frame
12 months
Title
Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups
Description
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
Title
The differential usage of anticoagulation therapy between two arms.
Description
The differential usage of anticoagulation therapy between two arms.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sultan M Siddique, MD
Organizational Affiliation
Prisma Health-Midlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palmetto Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Recurrence of Atrial Fibrillation Post Cryoballon Ablation During the 90-day Blanking Period-with and Without Anti-arrhythmic Drug Therapy
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