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

NCT ID: NCT04474054

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2021-12-21

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).

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FARAPULSE Ablation System Plus

Ablation using the FARAPULSE Ablation System Plus

Group Type: EXPERIMENTAL

Catheter ablation to treat paroxysmal atrial fibrillation

Intervention Type: DEVICE

A pulmonary vein isolation will be performed using catheter ablation

Interventions

Catheter ablation to treat paroxysmal atrial fibrillation

A pulmonary vein isolation will be performed using catheter ablation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ante Anic

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Split

Locations

KBC Split

Split, , Croatia

Countries

Croatia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CS0766

Identifier Type: -

Identifier Source: org_study_id