Clinical trial NCT04845750: The RODEO Micro Mapping Catheter in Cryoablation Procedures
Official title: The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Keywords: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Cryoablation
Cryosurgery
Mapping Catheter
Lead sponsor: afreeze GmbH
Sponsor class: OTHER
Collaborators: name: Competence Center for Medical Devices GmbH
First posted: 2021-04-15
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the Rodeo Micro Mapping Catheter
timeFrame: 1-3 hours
measure: Positioning of the Rodeo Micro Mapping Catheter
timeFrame: 1-3 hours
Secondary outcomes:
measure: Safety of the Rodeo Micro Mapping Catheter.
timeFrame: 1-3 day follow-up period
measure: Efficacy of the Rodeo Micro Mapping Catheter
timeFrame: 1-3 hours
measure: Real-time pulmonary vein isolation
timeFrame: 1-3 hours
measure: Procedural safety
timeFrame: 1-3 hours
measure: Total procedure time
timeFrame: 1-3 hours
measure: Cryoablation catheter procedure time
timeFrame: 1-3 hours
measure: Total fluoroscopy time and dose
timeFrame: 1-3 hours
measure: Cryoablation catheter fluoroscopy time and dose
timeFrame: 1-3 hours
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
state: Tirol
city: Neuwied
country: Germany
facility: Marienhaus Klinikum St. Elisabeth Neuwied
state: Rheinland-Pfalz
Study officials:
affiliation: Medizinische Universität Innsbruck
name: Florian Hintringer, MD
role: PRINCIPAL_INVESTIGATOR
References: