NCT04845750

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2021

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

April 12, 2021

Last Update Submit

July 20, 2022

Conditions

Atrial FibrillationParoxysmal Atrial FibrillationPersistent Atrial FibrillationArrhythmias, CardiacCardiovascular DiseasesHeart Diseases

Keywords

Atrial FibrillationParoxysmal Atrial FibrillationPersistent Atrial FibrillationCryoablationCryosurgeryMapping Catheter

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Safety of the Rodeo Micro Mapping Catheter.

    1-3 day follow-up period

  • Efficacy of the Rodeo Micro Mapping Catheter

    1-3 hours

  • Real-time pulmonary vein isolation

    1-3 hours

  • Procedural safety

    1-3 hours

  • Total procedure time

    1-3 hours

  • +3 more secondary outcomes

Study Arms (1)

Rodeo Micro Mapping Catheter

EXPERIMENTAL

Determination of pulmonary vein isoation during cryoablation procedure

Device: Rodeo Micro Mapping Catheter

Interventions

Rodeo Micro Mapping CatheterDEVICE

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

Rodeo Micro Mapping Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medizinische Universität Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Marienhaus Klinikum St. Elisabeth Neuwied

Neuwied, Rhineland-Palatinate, 56564, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacCardiovascular DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Florian Hintringer, MD

    Medizinische Universität Innsbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Kaiser, PhD

CONTACT

+43 (0)699 11073109andreas.kaiser@afreeze.com

afreeze GmbH

CONTACT

+43 (0)512 209012clinical.research@afreeze.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 15, 2021

Study Start

April 14, 2021

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

AU(1)DE(1)