PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation

NCT ID: NCT04170608

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2020-12-07

Brief Summary

PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation

Detailed Description

This is a prospective, multi-center, safety and feasibility study. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PEF ablation of additional arrhythmogenic locations. Subjects will be followed at 30 days, 75 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 Endocardial Ablation

Ablation using the FARAPULSE Endocardial Multi Ablation System

Group Type: EXPERIMENTAL

FARAPULSE Endocardial Multi Ablation System

Intervention Type: DEVICE

Ablation using the FARAPULSE Endocardial Multi Ablation System

Interventions

FARAPULSE Endocardial Multi Ablation System

Ablation using the FARAPULSE Endocardial Multi Ablation System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with documented drug-resistant symptomatic PAF meeting all three of the following criteria:

1. Confirmed AF: Documentation must include a recording such as ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, or telemetry strip, recorded within one year prior to enrollment and showing at least 30 seconds of AF.

2. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.

3. Failed atrial fibrillation drug (AFD) treatment, meaning therapeutic failure of at least one AFD (class I - IV) for efficacy and / or intolerance.

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. Atrial fibrillation that is any of the following:

1. Persistent (by diagnosis or duration > 7 days)

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

3. Requires ≥ 4 cardioversions in the preceding 12 months

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. Hemodynamically significant valvular disease

3. Prosthetic heart valve

4. NYHA Class III or IV CHF

5. Previous endocardial or epicardial ablation or surgery for AF

6. Atrial or ventricular septal defect closure

7. Atrial myxoma

8. Left atrial appendage device or occlusion

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

10. Significant or symptomatic hypotension

11. Bradycardia or chronotropic incompetence

12. History of pericarditis

13. History of rheumatic fever

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

4. Any of the following within 3 months of enrollment:

1. Myocardial infarction

2. Unstable angina

3. Percutaneous coronary intervention

4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)

5. Heart failure hospitalization

6. Stroke or TIA

7. Clinically significant bleeding

8. Pericarditis or pericardial effusion

9. Left atrial thrombus

5. History of blood clotting or bleeding abnormalities

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

7. Contraindications to CT or MRI

8. Sensitivity to contrast media not controlled by premedication

9. Women of childbearing potential who are pregnant, lactating or not using birth control

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

Petr Neuzil

Role: PRINCIPAL_INVESTIGATOR

Nemocnice Na Homolce

Locations

University Hospital of Split

Split, , Croatia

Nemocnice Na Homolce

Prague, , Czechia

Countries

Croatia; Czechia

References

Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

Reference Type: DERIVED

PMID: 33933412 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CS0571

Identifier Type: -

Identifier Source: org_study_id