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Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford Hospitals and Clinic
Palo Alto, California, United States
Adventist Health St. Helena
St. Helena, California, United States
Hartford Healthcare
Hartford, Connecticut, United States
St Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
ProMedica Toledo
Toledo, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Start Date
November 15, 2018
Primary Completion Date
October 1, 2024
Completion Date
December 1, 2026
Last Updated
March 5, 2026
160
ESTIMATED participants
Surgical Ablation
PROCEDURE
Cardioblate and Cryoflex hand held devices
DEVICE
Lead Sponsor
Medtronic Cardiac Surgery
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06765356