Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cryoablation, Cryosurgery, Mapping Catheter
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.
Interventions
DEVICERodeo Micro Mapping Catheter
The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation
Sponsors
Competence Center for Medical Devices GmbH
afreeze GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Rodeo Micro Mapping Catheter | 1-3 hours | Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter. |
| Positioning of the Rodeo Micro Mapping Catheter | 1-3 hours | Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-time pulmonary vein isolation | 1-3 hours | Time from beginning of the freeze to conduction blockade (time to effect) |
| Procedural safety | 1-3 hours | Procedure-related adverse events |
| Total procedure time | 1-3 hours | Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath |
| Safety of the Rodeo Micro Mapping Catheter. | 1-3 day follow-up period | Percentage of adverse events related to the Rodeo Micro Mapping Catheter |
| Total fluoroscopy time and dose | 1-3 hours | Total fluoroscopy time and dose defined from introduction of the transseptal sheath until removal of the transseptal sheath |
| Cryoablation catheter fluoroscopy time and dose | 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 |
| Cryoablation catheter procedure time | 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 |
| Efficacy of the Rodeo Micro Mapping Catheter | 1-3 hours | Percentage of successfully isolated pulmonary veins |
Countries
Austria, Germany
Contacts
Primary ContactAndreas Kaiser, PhD
Backup Contactafreeze GmbH
Outcome results
None listed