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| Name | Class |
|---|---|
| Raffeiner GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoolLoop® cryoablation system | Cryoablation for treatment of atrial fibrillation using the CoolLoop® cryoablation system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolLoop® cryoablation system | Device | Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events | Safety is measured by the percentage of participants with serious adverse events (SAEs) up to 36 months post-ablation | 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 | 36 months follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 and 24 months post-ablation |
| Acute procedure success |
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Inclusion Criteria:
Exclusion Criteria:
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Patients have to be planned and be suitable for an ablation procedure. The decision to treat the patients with the CoolLoop® cryoablation System has already been made in advance by the Investigator. Informed consent has to be obtained before the ablation procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Kaiser, PhD | Contact | +43 (0) 69911073109 | andreas.kaiser@afreeze.com | |
| afreeze GmbH | Contact | +43 (0) 512 209012 | 0 | clinical.research@afreeze.com |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Kaiser, PhD | afreeze GmbH | Study Director |
| Florian Hintringer, MD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Recruiting | Innsbruck | Tirol/Austria | 6020 | Austria |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
| 36 months follow-up period |
| Total procedure time | Total procedure time defined from introduction of the sheath until removal of the sheath | 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 | Estimated timeframe up to 2 hours |
| Total fluoroscopy time | Total fluoroscopy time defined from introduction of the sheath until removal of the sheath | 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 | 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 | Estimated timeframe up to 1 hour |
| Adverse Events (AEs) of special interest | Recording of AEs of Special interest and patient reported cardiac arrhythmias | 36 months follow-up period |
| Marienhaus Klinikum St. Elisabeth Neuwied | Not yet recruiting | Neuwied | Germany/Rheinland-Pfalz | 56564 | Germany |
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