STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation (STOP AF First)
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|ClinicalTrials.gov Identifier: NCT03118518|
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : August 11, 2021
Last Update Posted : August 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Fibrillation New Onset||Device: Cryoablation Drug: Antiarrhythmic drug||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation|
|Actual Study Start Date :||June 23, 2017|
|Actual Primary Completion Date :||June 25, 2020|
|Actual Study Completion Date :||June 25, 2020|
|Active Comparator: Anti-arrhythmic drug||
Drug: Antiarrhythmic drug
Antiarrhythmic drug initiation
Pulmonary vein isolation via ablation with cryoballoon catheter
Other Name: ArcticFront Advance Cardiac CryoAblation Catheter
- Percentage of Participants With Treatment Success at 12 Months After Antiarrhythmic Drug (AAD) Initiation or Ablation Utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter. [ Time Frame: Randomization to 12 months ]
Treatment success after AAD initiation (control arm) or pulmonary vein isolation ablation procedure utilizing the Arctic Front Advance™ Cardiac CryoAblation Catheter (treatment arm). Treatment success is the opposite of treatment failure. Treatment failure was defined as any of the following:
- Acute procedural failure (treatment arm only).
- Documented AF/AT/AFL on ambulatory monitoring/12-lead ECG after the 90-day post-ablation blanking period (treatment)/AAD optimization period (control arm). Minimum of 30 seconds on ambulatory monitoring or 10 seconds on 12-lead ECG.
- Any subsequent AF surgery or ablation in the left atrium.
- Any subsequent cardioversion after the 90-day post-ablation blanking period (treatment)/AAD optimization period (control arm).
- Class I or III antiarrhythmic drug (or sotalol) use after the 90-day blanking period (treatment arm only).
- Primary Safety Endpoint - Rate of Composite List of Serious Adverse Events. [ Time Frame: Randomization to 12 months ]
Measured by rate of composite list of serious adverse events in cryoablation-treated as randomized arm.
- TIA within 7 days
- Cerebrovascular accident within 7 days
- Major bleed that requires transfusion or results in a 20% or greater fall in hematocrit (HCT) within 7 days
- Development of a significant pericardial effusion within 30 days. (One that results in hemodynamic compromise, requires elective or urgent pericardiocentesis, or results in a 1-cm or more pericardial effusion as documented by echocardiography).
- Symptomatic PV stenosis within 12 months; accompanied by one of the following: 50%-75% reduction in diameter of the pulmonary vein, with symptoms not explained by other conditions; OR >75% reduction in diameter of the pulmonary vein
- MI within 7 days
- PNI unresolved at 12 months
- AE fistula within 12 months
- Major vascular complication that requires intervention, prolongs hospital stay, or requires hospital admission (within 7 days).
- Quality of Life Scores at Baseline Compared to 12 Months [ Time Frame: Baseline and 12 Months ]
There are two hypotheses tested in the objective, with separate hypothesis tests for (1) the difference in composite scores from the AFEQT questionnaire taken at baseline and 12 month visits, and (2) for the difference in composite scores for the EQ-5D questionnaire taken at baseline and 12-month visits.
Composite AFEQT score is on a scale of zero to one hundred. Higher scores are better.
Composite EQ-5D score is on a scale of zero to one. Higher scores are better.
- Healthcare Utilization [ Time Frame: Initial treatment through 12 months. ]Compare health care utilization between the treatment and control arms. There are two hypotheses tested in the objective, with separate hypothesis tests for: (1) the rate of total health care utilization events (cardiovascular-related hospitalizations, emergency room visits, or unscheduled office visits) over 12 months shown as freedom from cardiovascular health care utilization by treatment arm, and (2) freedom from cardioversions (electrical or pharmacological) over 12 months by treatment arm.
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): NCT03118518
|Principal Investigator:||Oussama Wazni, MD||The Cleveland Clinic|
|Principal Investigator:||Gopi Dandamudi, MD||Franciscan Heart & Vascular Associates at St. Joseph|
|Principal Investigator:||Steve Nissen, MD||The Cleveland Clinic|