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| Name | Class |
|---|---|
| Competence Center for Medical Devices GmbH | UNKNOWN |
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This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted).
Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rodeo Micro Mapping Catheter | Experimental | Determination of pulmonary vein isoation during cryoablation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rodeo Micro Mapping Catheter | Device | The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Rodeo Micro Mapping Catheter | Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter. | 1-3 hours |
| Positioning of the Rodeo Micro Mapping Catheter | Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible | 1-3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the Rodeo Micro Mapping Catheter. | Percentage of adverse events related to the Rodeo Micro Mapping Catheter | 1-3 day follow-up period |
| Efficacy of the Rodeo Micro Mapping Catheter | Percentage of successfully isolated pulmonary veins |
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Inclusion Criteria:
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 enrolment or high-risk surgical patients.
Left atrial diameter > 50 mm in the short axis.
Advanced structural heart disease including
Permanent pacemaker.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Kaiser, PhD | Contact | +43 (0)699 11073109 | andreas.kaiser@afreeze.com | |
| afreeze GmbH | Contact | +43 (0)512 209012 | 0 | clinical.research@afreeze.com |
| Name | Affiliation | Role |
|---|---|---|
| Florian Hintringer, MD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Recruiting | Innsbruck | Tyrol | 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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| 1-3 hours |
| Real-time pulmonary vein isolation | Time from beginning of the freeze to conduction blockade (time to effect) | 1-3 hours |
| Procedural safety | Procedure-related adverse events | 1-3 hours |
| Total procedure time | Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath | 1-3 hours |
| Cryoablation catheter procedure time | Cryoablation catheter procedure time defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application | 1-3 hours |
| Total fluoroscopy time and dose | Total fluoroscopy time and dose defined from introduction of the transseptal sheath until removal of the transseptal sheath | 1-3 hours |
| Cryoablation catheter fluoroscopy time and dose | Cryoablation catheter fluoroscopy time and dose defined from introduction of the cryoablation catheter into the left atrium until removal of the cryoablation catheter from the left atrium after termination of the last cryo-application | 1-3 hours |
| Marienhaus Klinikum St. Elisabeth Neuwied | Not yet recruiting | Neuwied | Rhineland-Palatinate | 56564 | Germany |
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