The RODEO Micro Mapping Catheter in Cryoablation Procedures

Cardiovascular Diseases Clinical Trial

— RODEO-MaPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845750
• Other study ID #: RODEO-MaPS
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2022
• Source: afreeze GmbH
• Contact: Andreas Kaiser, PhD
• Phone: +43 (0)699 11073109
• Email: andreas.kaiser[@]afreeze.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Rodeo Micro Mapping Catheter
The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck	Tirol
Germany	Marienhaus Klinikum St. Elisabeth Neuwied	Neuwied	Rheinland-Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
afreeze GmbH	Competence Center for Medical Devices GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Safety of the Rodeo Micro Mapping Catheter.	Percentage of adverse events related to the Rodeo Micro Mapping Catheter	1-3 day follow-up period
Secondary	Efficacy of the Rodeo Micro Mapping Catheter	Percentage of successfully isolated pulmonary veins	1-3 hours
Secondary	Real-time pulmonary vein isolation	Time from beginning of the freeze to conduction blockade (time to effect)	1-3 hours
Secondary	Procedural safety	Procedure-related adverse events	1-3 hours
Secondary	Total procedure time	Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath	1-3 hours
Secondary	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
Secondary	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
Secondary	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