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

NCT06557616 | Recruiting

• 1 other identifier: BK_CIP-02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation, Paroxysmal or Persistent; Mitral Valve Disease

Keywords

cryoablation; cardiac cryoablation; arrhythmia; atrial fibrillation; mitral valve; concomitant ablation

Outcome Measures

Primary Outcomes (2)

• 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

  12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure

• Incidence of adverse events and serious adverse events related to the use of the

  Recording of adverse events/serious life-threatening events.

  6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure

Secondary Outcomes (3)

• The occurrence of serious adverse events during surgery (intraoperatively) or after the procedure until the patient is discharged from the unit (postoperatively).

  During the procedure, 6 day (+/- 1 day) after the procedure

• Incidence of all adverse events and serious adverse events at 6-month follow-up after surgery.

  6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure

• The proportion of patients who had a return to sinus rhythm at 3 and 6 months postoperatively.

  12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• Lack of written consent from the patient to participate in the study.
• Contraindications to the cryoablation procedure.
• Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.
• co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia).
• significant calcification of the left atrium.
• Condition after previous cardiac surgery.
• significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection).
• the patient is currently a participant in another clinical trial.
• The patient is on active biological therapy.
• emergency surgery.
• Life expectancy \<12 months.
• Any circumstances that, in the opinion of the Investigator, may prevent the patient from participating in the study, limit the ability to perform the procedures outlined in the study protocol or place an unreasonable risk on the patient.

Sponsors & Collaborators

• Medinice S.A.: lead

Study Sites (2)

Antoni Jurasz University Hospital No. 1

Bydgoszcz, 85-094, Poland

RECRUITING

Silesian Centre for Heart Diseases

Zabrze, 41-800, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomasz Hrapkowicz, MD PhD

  Silesian Centre for Heart Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Hrapkowicz, MD PhD

CONTACT

+48-519-136-533; t.hrapkowicz@sccs.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

PL (2)