Evaluation of the Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation in a Single-arm, Non-randomised, Open-label Clinical Trial
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke, heart failure and death.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Written consent from the patient to participate in the study.
• age ≥18 years.
• patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement with or without left atrial appendage closure).
• a documented diagnosis of co-occurrence of paroxysmal or persistent atrial fibrillation (AF) since at least 3 months prior to surgery with exclusion of acute conditions.
Locations
Other Locations
Poland
Antoni Jurasz University Hospital No. 1
RECRUITING
Bydgoszcz
Silesian Centre for Heart Diseases
RECRUITING
Zabrze
Contact Information
Primary
Tomasz Hrapkowicz, MD PhD
t.hrapkowicz@sccs.pl
+48-519-136-533
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Medinice S.A.