TERMINATED

Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Conditions

Atrial Fibrillation Paroxysmal pulsed field ablation paroxysmal atrial fibrillation left atrium posterior wall isolation pulmonary vein isolation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).

Official Title

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

Quick Facts

Study Start:2024-10-08

Study Completion:2025-11-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06364215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age 21-90 years. 4. Symptomatic PAF whether failed AAD or not. 5. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment. 6. Patients undergoing first time ablation for AF. 7. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.	1. Persistent atrial fibrillation (PeAF) (\> 7 days in duration). 2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause. 3. Previous surgical or catheter ablation of AF. 4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve. 5. Left atrium anteroposterior (LA AP) diameter \>55 mm or indexed left atrium (LA) volume \>48 ml/m2. 6. Contraindications to oral or systemic anticoagulation. 7. Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months. 8. Previous myocardial infarction or percutaneous coronary intervention within the past 2 months. 9. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days). 10. Pregnancy. 11. History of PV stenosis. 12. History of severe pulmonary hypertension. 13. History of diaphragmatic paresis or hemi-paresis. 14. History of heart transplantation. 15. History of blood clotting or bleeding abnormalities. 16. Life expectancy of less than 12 months. 17. Presence of intracardiac thrombus. 18. Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries. 19. Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA. 20. Pacing dependent patients. 21. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma). 22. Active systemic infection. 23. Participation in any other AF-related randomized clinical trial.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age 21-90 years.
4. Symptomatic PAF whether failed AAD or not.
5. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
6. Patients undergoing first time ablation for AF.
7. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.

1. Persistent atrial fibrillation (PeAF) (\> 7 days in duration).
2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.
3. Previous surgical or catheter ablation of AF.
4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.
5. Left atrium anteroposterior (LA AP) diameter \>55 mm or indexed left atrium (LA) volume \>48 ml/m2.
6. Contraindications to oral or systemic anticoagulation.
7. Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.
8. Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
9. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
10. Pregnancy.
11. History of PV stenosis.
12. History of severe pulmonary hypertension.
13. History of diaphragmatic paresis or hemi-paresis.
14. History of heart transplantation.
15. History of blood clotting or bleeding abnormalities.
16. Life expectancy of less than 12 months.
17. Presence of intracardiac thrombus.
18. Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries.
19. Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA.
20. Pacing dependent patients.
21. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).
22. Active systemic infection.
23. Participation in any other AF-related randomized clinical trial.

Contacts and Locations

Principal Investigator

Jorge E Romero, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

William H Sauer, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Grandview Medical Center

Birmingham, Alabama, 35243

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010

United States

St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's

Jacksonville, Florida, 32204

United States

HCA Florida Mercy Hospital

Miami, Florida, 33133

United States

St. Luke's Boise Medical Center

Boise, Idaho, 83712

United States

Maine Medical Center

Portland, Maine, 04102

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805

United States

Corewell Health William Beaumont Hospital

Royal Oak, Michigan, 48073

United States

The Valley Hospital

Paramus, New Jersey, 07652

United States

North Shore University Hospital, Northwell Health

Manhasset, New York, 11030

United States

Doylestown Hospital

Doylestown, Pennsylvania, 18901

United States

Trident Medical Center

Charleston, South Carolina, 29406

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Orion Medical

Houston, Texas, 77034

United States

Methodist Hospital-San Antonio

San Antonio, Texas, 78229

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Jorge E Romero, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital
William H Sauer, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-08

Study Completion Date2025-11-16

Study Record Updates

Study Start Date2024-10-08

Study Completion Date2025-11-16

Terms related to this study

Keywords Provided by Researchers

pulsed field ablation
paroxysmal atrial fibrillation
left atrium posterior wall isolation
pulmonary vein isolation

Additional Relevant MeSH Terms

Atrial Fibrillation Paroxysmal