Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedinice S.A.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Lack of written consent from the patient to participate in the study.
Failure to meet the inclusion criteria.
Contraindications to the cryoablation procedure.
Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.
Trial population
Sixteen patients, male and female, aged ≥18 years, qualified for mitral heart valve surgery with documented (in at least one ECG recording) co-occurrence of paroxysmal or persistent atrial fibrillation (AF) will undergo the procedure with the medical device. There is also a prediction of 10 per cent of patients (screen failure) who do not meet the inclusion and/or exclusion criteria after signing informed consent. Additionally, there may be perioperative situations where the cryoablation procedure is not performed due to potential acute aortic dissection or undiagnosed conditions necessitating a change in surgical tactics (e.g. pericarditis). It is estimated that the above situation may affect 1-2 study participants who will be given drop-out status.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Percentage of patients with no documented recurrence of atrial fibrillation on continuous 48h Holter ECG recording during 6-month follow-up.
To verify whether atrial fibrillation is present in the recordings obtained during 48h Holter. ECG monitorin
Time frame
12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure2
Incidence of adverse events and serious adverse events related to the use of the
Recording of adverse events/serious life-threatening events.
Time frame
6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedureSecondary outcomes
1
The occurrence of serious adverse events during surgery (intraoperatively) or after the procedure until the patient is discharged from the unit (postoperatively).
Recording of all adverse events/serious life-threatening events.
Time frame
During the procedure, 6 day (+/- 1 day) after the procedure2
Incidence of all adverse events and serious adverse events at 6-month follow-up after surgery.
Recording of all adverse events/serious life-threatening events.
Time frame
6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure3
The proportion of patients who had a return to sinus rhythm at 3 and 6 months postoperatively.
To verify whether sinus rhythm is present in the recordings obtained during 48h Holter ECG monitoring.
Time frame
12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedureSponsors and contacts
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Source ClinicalTrials.gov