Status:
UNKNOWN
The RODEO Micro Mapping Catheter in Cryoablation Procedures
Lead Sponsor:
afreeze GmbH
Collaborating Sponsors:
Competence Center for Medical Devices GmbH
Conditions:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04845750
Start Date
April 14 2021
End Date
January 31 2023
Last Update
July 21 2022
Active Locations (2)
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1
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria, 6020
2
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Rhineland-Palatinate, Germany, 56564