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

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Status

Enrolling

Conditions

Paroxysmal Atrial Fibrillation

Atrial Fibrillation

Arrhythmias, Cardiac

Persistent Atrial Fibrillation

Cardiovascular Diseases

Heart Diseases

Treatments

Device: Rodeo Micro Mapping Catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT04845750

RODEO-MaPS

Details and patient eligibility

About

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.

Enrollment

37 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.