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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 90
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Age 21-90 years.

• Symptomatic PAF whether failed AAD or not.

• 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.

• Patients undergoing first time ablation for AF.

• Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.

Locations
United States
Alabama
Grandview Medical Center
RECRUITING
Birmingham
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's
RECRUITING
Jacksonville
HCA Florida Mercy Hospital
RECRUITING
Miami
Idaho
St. Luke's Boise Medical Center
RECRUITING
Boise
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Lahey Hospital and Medical Center
RECRUITING
Burlington
Maine
Maine Medical Center
RECRUITING
Portland
Michigan
Corewell Health William Beaumont Hospital
RECRUITING
Royal Oak
New Jersey
The Valley Hospital
RECRUITING
Paramus
New York
North Shore University Hospital, Northwell Health
RECRUITING
Manhasset
Pennsylvania
Doylestown Hospital
RECRUITING
Doylestown
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Trident Medical Center
RECRUITING
Charleston
Texas
Orion Medical
RECRUITING
Houston
Methodist Hospital-San Antonio
RECRUITING
San Antonio
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Washington
University of Washington Medical Center
RECRUITING
Seattle
Contact Information
Primary
Obadah Aloum, MD
oaloum@bwh.harvard.edu
6177325241
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2028-10
Participants
Target number of participants: 450
Treatments
Active_comparator: Pulmonary Vein Isolation (PVI) only
Pulsed field ablation of the pulmonary veins only.
Active_comparator: Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)
Pulsed field ablation of the pulmonary veins and the posterior wall of the left atrium.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Databean, Boston Scientific Corporation

This content was sourced from clinicaltrials.gov