Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06557616

Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation

Sponsor: Medinice S.A.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2024-07-03

Completion Date

2026-06-30

Last Updated

2025-09-23

Healthy Volunteers

No

Locations (2)

Antoni Jurasz University Hospital No. 1

Bydgoszcz, Poland

Silesian Centre for Heart Diseases

Zabrze, Poland