Treatment Success With the CoolLoop Cryoablation System

afreeze

Status

Enrolling

Conditions

Paroxysmal Atrial Fibrillation

Atrial Fibrillation

Arrhythmias, Cardiac

Persistent Atrial Fibrillation

Cardiovascular Diseases

Heart Diseases

Treatments

Device: CoolLoop® cryoablation system

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03818724

CooL-TreatS

Details and patient eligibility

About

This clinical study evaluates the safety and efficacy of the treatment with the CoolLoop® cryoablation System (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted) over a follow-up period of 36 months.

A further aim of this study is to evaluate the average duration of procedure and fluoroscopy times.

Enrollment

540 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
atrial fibrillation: permanent AF excepted
ECG documented AF within the last 6 months
patients planned for an ablation procedure and suitable and planned for treatment with the CoolLoop® cryoablation system
signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment (patient has received a copy of the ICF)

Exclusion criteria

indication that the vascular system is not accessible through the left or right groin.
indication that a transseptal puncture cannot be performed.
any previous ablation or surgery due to AF.
important comorbidities such as cardiovascular events within six months of enrollment or high-risk surgical patients.
pregnant women at the time of the cryoablation procedure.
any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
participation in interventional trials for cardiovascular devices or drugs.