• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


           

Real-World Experience of Catheter Ablation of PsAF


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P030031 S100/ PAS001
Date Current Protocol Accepted 05/13/2021
Study Name Real-World Experience of Catheter Ablation of PsAF
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 Design Description 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 Description 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.
Data Collection 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 Safety Information First 6-month report, interim results not available.
Actual Number of Patients Enrolled 241/350
Actual Number of Sites Enrolled Electronic Health Record (EHR)-based study including approximately 45 hospitals.
Patient Follow-up Rate 92.53% at 30 days, 84.65% at 90 days, 73.03% at 6 months, 45.64% at 1 year, 19.09% at 2 years, 3.73% at 3 years
Study Strengths & Weaknesses N/A as of this report.


Real-World Experience of Catheter Ablation of PsAF Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/29/2021 06/29/2021 On Time
1 year report 09/30/2021    
18 month report 03/31/2022    
2 year report 09/30/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

-
-