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

July 20, 2022 updated by: afreeze GmbH

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

afreeze GmbH

Collaborators

Competence Center for Medical Devices GmbH

Investigators

  • Principal Investigator: Florian Hintringer, MD, Medizinische Universität Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on Rodeo Micro Mapping Catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe