The RODEO Micro Mapping Catheter in Cryoablation Procedures

Not Applicable

• Conditions: Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Interventions: Device: Rodeo Micro Mapping Catheter

• Registration Number: NCT04845750
• Lead Sponsor: afreeze GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study Start: 2021-04-14
• Study First Posted: 2021-04-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rodeo Micro Mapping Catheter	Rodeo Micro Mapping Catheter	Determination of pulmonary vein isoation during cryoablation procedure

Primary Outcome Measures

Name	Time	Method
Positioning of the Rodeo Micro Mapping Catheter	1-3 hours	Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible
Feasibility of the Rodeo Micro Mapping Catheter	1-3 hours	Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter.

Secondary Outcome Measures

Name	Time	Method
Real-time pulmonary vein isolation	1-3 hours	Time from beginning of the freeze to conduction blockade (time to effect)
Total fluoroscopy time and dose	1-3 hours	Total fluoroscopy time and dose defined from introduction of the transseptal sheath until removal of the transseptal sheath
Procedural safety	1-3 hours	Procedure-related adverse events
Safety of the Rodeo Micro Mapping Catheter.	1-3 day follow-up period	Percentage of adverse events related to the Rodeo Micro Mapping Catheter
Efficacy of the Rodeo Micro Mapping Catheter	1-3 hours	Percentage of successfully isolated pulmonary veins
Total procedure time	1-3 hours	Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath
Cryoablation catheter procedure time	1-3 hours	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
Cryoablation catheter fluoroscopy time and dose	1-3 hours	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

Trial Locations

Locations (2)

Marienhaus Klinikum St. Elisabeth Neuwied; 🇩🇪 Neuwied, Rheinland-Pfalz, Germany

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria