Treatment Success With the CoolLoop Cryoablation System

afreeze GmbH540 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

540

Conditions

Atrial Fibrillation Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Medical University Innsbruck

Innsbruck, Tirol/Austria, Austria

RECRUITING

Marienhaus Klinikum St. Elisabeth Neuwied

Neuwied, Germany/Rheinland-Pfalz, Germany

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Incidence of serious adverse events

Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation

Time frame: 36 months follow-up period

Freedom from atrial fibrillation (efficacy) at 36 months post-ablation

Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation

Time frame: 36 months follow-up period

Secondary Outcomes

Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation

Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 12 and 24 months post-ablation

Time frame: 12 and 24 months post-ablation

Acute procedure success

Acute efficacy of isolation of each of the pulmonary veins defined as the percentage of diagnostic mapping catheter electrode pairs within the pulmonary vein without any detectable pulmonary vein signal in case of redo procedure

Time frame: 36 months follow-up period

Total procedure time

Total procedure time defined from introduction of the sheath until removal of the sheath

Time frame: Estimated timeframe up to 4 hours

CoolLoop procedure time

CoolLoop procedure time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after Termination of the last cryo-application with the CoolLoop cryoablation catheter

Time frame: Estimated timeframe up to 2 hours

Total fluoroscopy time

Total fluoroscopy time defined from introduction of the sheath until removal of the sheath

Time frame: Estimated time frame up to 1 hour

CoolLoop fluoroscopy time

CoolLoop fluoroscopy time defined from introduction of the CoolLoop cryoablation catheter into the left atrium until removal from the left atrium after termination of the last cryo-application with the CoolLoop cryoablation catheter

Time frame: Estimated timeframe up to 30 minutes

Cumulative cryoablation time

Cumulative cryoablation time is displayed as "total freeze time" by the cryoconsole at the end of the procedure

Time frame: Estimated timeframe up to 1 hour

Adverse Events (AEs) of special interest

Recording of AEs of Special interest and patient reported cardiac arrhythmias

Time frame: 36 months follow-up period

Treatment Success With the CoolLoop Cryoablation System

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts