Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryosurgery
Brief summary
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.
Interventions
DEVICECoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
Sponsors
Raffeiner GmbH
afreeze GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse events | 36 months follow-up period | Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation |
| Freedom from atrial fibrillation (efficacy) at 36 months post-ablation | 36 months follow-up period | Efficacy is measured by the percentage of AF (atrial fibrillation) free patients at 36 months post-ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedure time | Estimated timeframe up to 4 hours | Total procedure time defined from introduction of the sheath until removal of the sheath |
| CoolLoop procedure time | Estimated timeframe up to 2 hours | 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 |
| Total fluoroscopy time | Estimated time frame up to 1 hour | Total fluoroscopy time defined from introduction of the sheath until removal of the sheath |
| Freedom from atrial fibrillation (efficacy) at 12 and 24 months post-ablation | 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 |
| Cumulative cryoablation time | Estimated timeframe up to 1 hour | Cumulative cryoablation time is displayed as total freeze time by the cryoconsole at the end of the procedure |
| Adverse Events (AEs) of special interest | 36 months follow-up period | Recording of AEs of Special interest and patient reported cardiac arrhythmias |
| CoolLoop fluoroscopy time | Estimated timeframe up to 30 minutes | 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 |
| Acute procedure success | 36 months follow-up period | 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 |
Countries
Austria, Germany
Contacts
Primary ContactAndreas Kaiser, PhD
Backup Contactafreeze GmbH
Outcome results
None listed