The RODEO Micro Mapping Catheter in Cryoablation Procedures (RODEO-MaPS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Rodeo Micro Mapping Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Kaiser, PhD; Phone Number: +43 (0)699 11073109; Email: andreas.kaiser@afreeze.com
• Study Contact Backup: Name: afreeze GmbH; Phone Number: +43 (0)512 209012; Email: clinical.research@afreeze.com

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Medizinische Universität Innsbruck
• Germany
  • Rheinland-Pfalz
    • Neuwied, Rheinland-Pfalz, Germany, 56564
      • Not yet recruiting
      • Marienhaus Klinikum St. Elisabeth Neuwied

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: afreeze GmbH
• Collaborators: Competence Center for Medical Devices GmbH
• Investigators: Principal Investigator: Florian Hintringer, MD, Medizinische Universität Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cryoablation; Persistent Atrial Fibrillation; Cryosurgery; Paroxysmal Atrial Fibrillation; Mapping Catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: RODEO-MaPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No