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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|ClinicalTrials.gov Identifier: NCT02913014|
Recruitment Status : Unknown
Verified September 2018 by Sultan Siddique, MD, Prisma Health-Midlands.
Recruitment status was: Recruiting
First Posted : September 23, 2016
Last Update Posted : September 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: No AAD post Ablation.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||June 28, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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 Name: 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.
- Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period.
- The cost of AADs during the 90-day blanking period. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 12 months ]The differential usage of anticoagulation therapy between two arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913014
|Contact: Evelyn J Kennedy, MSNfirstname.lastname@example.org|
|Contact: Michael Haney, MEemail@example.com|
|United States, South Carolina|
|Columbia, South Carolina, United States, 29203|
|Principal Investigator:||Sultan M Siddique, MD||Prisma Health-Midlands|