Atrial Fibrillation
Conditions
Keywords
Antiarrhythmic Agents, Catheter Ablation, electric, Cardiac Arrhythmias, Anti-Arrhythmia Drugs
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.
Interventions
OTHERNo AAD post Ablation.
Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation
Sponsors
Medtronic
Prisma Health-Midlands
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| The cost of AADs during the 90-day blanking period. | 12 months | 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 | 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 |
| The differential usage of anticoagulation therapy between two arms. | 12 months | The differential usage of anticoagulation therapy between two arms. |
Countries
United States
Outcome results
None listed