Treatment Success With the CoolLoop Cryoablation System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CoolLoop® cryoablation system Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system |
Device: CoolLoop® cryoablation system
Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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atrial fibrillation: permanent AF excepted
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ECG documented AF within the last 6 months
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patients planned for an ablation procedure and suitable and planned for treatment with the CoolLoop® cryoablation system
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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:
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indication that the vascular system is not accessible through the left or right groin.
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indication that a transseptal puncture cannot be performed.
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any previous ablation or surgery due to AF.
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important comorbidities such as cardiovascular events within six months of enrollment or high-risk surgical patients.
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pregnant women at the time of the cryoablation procedure.
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any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
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participation in interventional trials for cardiovascular devices or drugs.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University Innsbruck | Innsbruck | Tirol/Austria | Austria | 6020 |
| 2 | Marienhaus Klinikum St. Elisabeth Neuwied | Neuwied | Germany/Rheinland-Pfalz | Germany | 56564 |
Sponsors and Collaborators
- afreeze GmbH
- Raffeiner GmbH
Investigators
- Study Director: Andreas Kaiser, PhD, afreeze GmbH
- Principal Investigator: Florian Hintringer, MD, Medical University Innsbruck
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CooL-TreatS