The RODEO Micro Mapping Catheter in Cryoablation Procedures

Study Overview
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Brief Summary
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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.

Official Title
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The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study

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

Intervention / Treatment
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* Device: Rodeo Micro Mapping Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and legal capacity. Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version 2016) - permanent AF excluded. Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU). 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 enrolment (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 enrolment or high-risk surgical patients. Left atrial diameter > 50 mm in the short axis. Advanced structural heart disease including moderate-to-severe valvular stenosis or regurgitation, previous valve replacement or valve repair, congenital heart disease, left ventricular ejection fraction < 45% during sinus rhythm, congestive heart failure NYHA III or IV, coronary artery bypass graft surgery within the last 3 months. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rodeo Micro Mapping Catheter<br>Determination of pulmonary vein isoation during cryoablation procedure | Device: Rodeo Micro Mapping Catheter<br>* The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoablation, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cryosurgery, Mapping Catheter