A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— FARA-Free  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474054
• Other study ID #: CS0766
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: April 2023
• Source: Farapulse, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

1. Lives locally.

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

3. 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:

1. Persistent

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

3. Longstanding

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

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

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

2. Previous endocardial or epicardial ablation or surgery for AF

3. Hemodynamically significant valvular disease

4. Prosthetic heart valve

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

6. Atrial or ventricular septal defect closure

7. Atrial myxoma

8. Left atrial thrombus

9. Left atrial appendage device or occlusion

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

11. Significant or symptomatic hypotension

12. Bradycardia or chronotropic incompetence

13. History of pericarditis

14. History of rheumatic fever

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

16. Any pulmonary vein abnormality, stenosis or stenting

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

a. Within the 3 months preceding enrollment:

i. Myocardial infarction

ii. Unstable angina

iii. Percutaneous coronary intervention

iv. Treatment with amiodarone

b. Within the 6 months preceding enrollment:

i. Heart surgery

ii. Stroke or TIA

iii. Any thromboembolic event

iv. Carotid stenting or endarterectomy

v. Pericarditis or pericardial effusion

c. Within the 12 months following enrollment:

i. Any likelihood of cardiac surgery or transplant

5. History of blood clotting or bleeding abnormalities.

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

7. Contraindications to both CT and MRI

8. Sensitivity to contrast media not controlled by premedication

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

10. 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

1. Body mass index (BMI) > 40

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

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

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

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

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

7. Clinically significant infection

8. Predicted life expectancy less than one year

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

12. Current or anticipated enrollment in any other clinical study

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Catheter ablation to treat paroxysmal atrial fibrillation
A pulmonary vein isolation will be performed using catheter ablation

Locations

Country	Name	City	State
Croatia	KBC Split	Split

Sponsors (1)

Lead Sponsor	Collaborator
Farapulse, Inc.

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events	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.	7 days to12 Months
Primary	Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter	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.	12 months