FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation

• Sponsor: Farapulse, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04474054
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).

Condition or Disease	Intervention/Treatment	Phase
Paroxysmal Atrial Fibrillation	Device: Catheter ablation to treat paroxysmal atrial fibrillation	N/A

Detailed Description

This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
• Actual Study Start Date: Jul 7, 2020
• Actual Primary Completion Date: Dec 21, 2021
• Actual Study Completion Date: Dec 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FARAPULSE Ablation System Plus Ablation using the FARAPULSE Ablation System Plus	Device: Catheter ablation to treat paroxysmal atrial fibrillation; A pulmonary vein isolation will be performed using catheter ablation

Outcome Measures

Primary Outcome Measures

1. Incidence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events [7 days to12 Months]

   Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.

Secondary Outcome Measures

1. Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter [12 months]

   Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:Study subjects are required to meet all the following inclusion criteria to participate in this study:

1. Patients with documented drug resistant symptomatic PAF

2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.

3. Patient participation requirements:

4. Lives locally.

5. Is willing and capable of providing Informed Consent to undergo study procedures.

6. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria: Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:

1. AF that is:

2. Persistent

3. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes

4. Longstanding

5. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)

6. Any of the following cardiac procedures, implants or conditions:

7. Clinically significant arrhythmias other than AF, AFL or AT

8. Previous endocardial or epicardial ablation or surgery for AF

9. Hemodynamically significant valvular disease

10. Prosthetic heart valve

11. Heart Failure for example NYHA Class III or IV CHF, LVEF <40%, Heart failure hospitalization

12. Atrial or ventricular septal defect closure

13. Atrial myxoma

14. Left atrial thrombus

15. Left atrial appendage device or occlusion

16. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices

17. Significant or symptomatic hypotension

18. Bradycardia or chronotropic incompetence

19. History of pericarditis

20. History of rheumatic fever

21. History of congenital heart disease with any residual anatomic or conduction abnormality

22. Any pulmonary vein abnormality, stenosis or stenting

23. Any of the following cardiovascular procedures, implants, or conditions:

1. Within the 3 months preceding enrollment:

2. Myocardial infarction

1. Unstable angina

2. Percutaneous coronary intervention

3. Treatment with amiodarone

1. Within the 6 months preceding enrollment:

2. Heart surgery

1. Stroke or TIA

2. Any thromboembolic event

3. Carotid stenting or endarterectomy

4. Pericarditis or pericardial effusion

1. Within the 12 months following enrollment:

2. Any likelihood of cardiac surgery or transplant

1. History of blood clotting or bleeding abnormalities.

2. Contraindication to, or unwillingness to use, systemic anticoagulation

3. Contraindications to both CT and MRI

4. Sensitivity to contrast media not controlled by premedication

5. Women of childbearing potential who are pregnant, lactating, not using birth control or planning to become pregnant during the anticipated study period

6. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to

7. Body mass index (BMI) > 40

8. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant

9. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea

10. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant

11. Active malignancy or history of treated cancer within 24 months of enrollment

12. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux

13. Clinically significant infection

14. Predicted life expectancy less than one year

15. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements

16. Current or anticipated enrollment in any other clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KBC Split	Split		Croatia

Sponsors and Collaborators

• Farapulse, Inc.

Investigators

• Principal Investigator: Ante Anic, University Hospital of Split

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Farapulse, Inc.
• ClinicalTrials.gov Identifier: NCT04474054
• Other Study ID Numbers: CS0766
• First Posted: Jul 16, 2020
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 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: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Farapulse, Inc.: Catheter Ablation; Paroxysmal Atrial Fibrillaltion; Pulmonary Vein Isolation; Atrial Fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jul 27, 2022