|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P030031 S100/ PAS001 |
| Date Original Protocol Accepted |
03/26/2021
|
| Date Current Protocol Accepted |
05/13/2021
|
| Study Name |
Real-World Experience of Catheter Ablation of PsAF
|
| Device Name |
THERMOCOOL SMARTTOUCH® SF Catheter
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
Other Data Source
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Single-arm, retrospective analysis of prospectively collected EHR, observational cohort study to demonstrate the long-term and continued safety and effectiveness of ablation for persistent atrial fibrillation with the THERMOCOOL SMARTTOUCH SF catheter in the real-world setting.
Primary Objective: To demonstrate the long-term effectiveness and safety of ablation for persistent atrial fibrillation (PsAF) with the THERMOCOOL SMARTTOUCH SF catheter in the real-world setting among patients followed for up to 36 months
Secondary Objective: To identify predictors of clinical outcomes of ablation among patients with PsAF in the real-world setting.
|
| Study Population |
PsAF patients aged 18 years or older and who underwent first time catheter ablation with the THERMOCOOL SMARTTOUCH SF Catheter.
|
| Sample Size |
A total of 350 consecutive eligible PsAF patients.
|
| Key Study Endpoints |
Primary Safety Endpoint: A composite of primary adverse events (PAEs) that occurred within 7 days* following ablation procedure:
• Atrio-esophageal fistula*
• Cardiac tamponade/perforation*
• Death*
• Acute myocardial infarction
• Acute stroke/cerebrovascular accident
• Thromboembolism
• Transient ischemic attack (TIA)
• Diaphragmatic paralysis
• Pneumothorax
• Heart block
• Pulmonary vein stenosis*
• Pulmonary edema
• Pericarditis
• Major vascular access complications/bleeding requiring transfusion
*Death, pulmonary vein stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure up to 3 months, and cardiac tamponade/perforation that occurred greater than one week (7 days) post-procedure up to 30 days will be considered and analyzed as PAEs.
Primary Effectiveness Endpoint: A composite of direct current cardioversion for atrial arrhythmia (AF/atrial tachycardia [AT]/atrial flutter [AFL]*), repeat ablation for AF/AT/AFL*, or hospitalization for AF/AT/AFL* at 12-month follow-up (with a 3-month blanking period)
* including atypical atrial flutter
Secondary Endpoints
• Procedural data (procedure time, fluoroscopy time)
• Repeat ablations through 1-year, 2-year, and 3-year
• All-cause hospitalization through 1-year, 2-year, and 3-year
• Cardiovascular (including heart failure related) hospitalization through 1-year, 2-year, and 3-year
• Direct current cardioversions through 1-year, 2-year, and 3-year
• Composite effectiveness endpoint without blanking period at 1-year follow-up
• Composite effectiveness endpoint through 2-year and 3-year
• Complications at 1-year, 2-year, and 3-year
|
| Follow-up Visits and Length of Follow-up |
Follow-up data are extracted from the EHR. Length of Follow-up: 3 years. Frequency of Follow-up: Per standard of care.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Findings
The cumulative incidence of the primary composite safety endpoint during the safety evaluation period was 0.90%
Effectiveness Findings
The cumulative incidence of the primary composite effectiveness endpoint at 1-year follow-up with a 3-month blanking period was 17.80%.
|
| Actual Number of Patients Enrolled |
558
|
| Actual Number of Sites Enrolled |
registry based study
|
| Patient Follow-up Rate |
Rate: Not available.
558 had index ablation procedure that occurred at least one year before the database refresh date of May 30, 2023. Target enrollment was 350, excellent follow up (~98.39% at 1 year)
|
| Study Strengths & Weaknesses |
N/A
|
