The RODEO Micro Mapping Catheter in Cryoablation Procedures

  • STATUS
    Recruiting
  • days left to enroll
    54
  • participants needed
    37
  • sponsor
    afreeze GmbH
Updated on 16 August 2021
fibrillation
catheter ablation
pulmonary vein isolation
permanent atrial fibrillation

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.

Details
Condition Arrhythmia, Atrial Fibrillation, Heart disease, Cardiovascular Disease, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Cardiac Disease, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder, paroxysmal af, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders
Treatment Rodeo Micro Mapping Catheter
Clinical Study IdentifierNCT04845750
Sponsorafreeze GmbH
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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