FARA1000: Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05501873
• Collaborator: (none)
• Enrollment: 1,000
• Anticipated Duration (Months): 48

Study Details

Study Description

Brief Summary

The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response.

Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death.

This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ PFA System is used per hospitals' standard of care.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: FARAPULSE Pulsed Field Ablation system

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Feb 15, 2027
• Anticipated Study Completion Date: Feb 15, 2027

Outcome Measures

Primary Outcome Measures

1. Primary Effectiveness Endpoint [12 monhts]

   Failure-free rate at 12 months post index procedure

Secondary Outcome Measures

1. Safety endpoint [12 months]

   Composite of device- or procedure-related SAEs at early onset or chronic onset

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care

2. Subjects who are willing and capable of providing informed consent

3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center

4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Previous intra-atrial septal patch

2. Known or suspected atrial myxoma

3. Myocardial Infarctions within 14 days prior to enrollment

4. Unstable angina at time of enrollment

5. Recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)

6. Patients who do not tolerate anticoagulation therapy

7. Patients with an active systemic infection

8. Presence of atrial known thrombus

9. Known inability to obtain vascular access

10. Pregnant or planning to be pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT05501873
• Other Study ID Numbers: PF114
• First Posted: Aug 16, 2022
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Aug 16, 2022