The RODEO Micro Mapping Catheter in Cryoablation Procedures
NCT ID: NCT04845750
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
37 participants
INTERVENTIONAL
2021-04-14
2023-01-31
Brief Summary
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Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rodeo Micro Mapping Catheter
Determination of pulmonary vein isoation during cryoablation procedure
Rodeo Micro Mapping Catheter
The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation
Interventions
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Rodeo Micro Mapping Catheter
The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Competence Center for Medical Devices GmbH
UNKNOWN
afreeze GmbH
OTHER
Responsible Party
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Principal Investigators
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Florian Hintringer, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Universität Innsbruck
Locations
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Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Florian Hintringer, MD
Role: primary
Burkhard Hügl, MD
Role: primary
Other Identifiers
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RODEO-MaPS
Identifier Type: -
Identifier Source: org_study_id
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