Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-04-21 @ 9:13 PM
Study NCT ID:
NCT04845750
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The RODEO Micro Mapping Catheter in Cryoablation Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the Rodeo Micro Mapping Catheter', 'timeFrame': '1-3 hours', 'description': 'Percentage of pulmonary veins with diagnostically conclusive signals measured with the RODEO Micro Mapping Catheter.'}, {'measure': 'Positioning of the Rodeo Micro Mapping Catheter', 'timeFrame': '1-3 hours', 'description': 'Percentage of pulmonary veins where positioning of the cryoablation catheter with the Rodeo Micro Mapping Catheter as guidewire was possible'}], 'secondaryOutcomes': [{'measure': 'Safety of the Rodeo Micro Mapping Catheter.', 'timeFrame': '1-3 day follow-up period', 'description': 'Percentage of adverse events related to the Rodeo Micro Mapping Catheter'}, {'measure': 'Efficacy of the Rodeo Micro Mapping Catheter', 'timeFrame': '1-3 hours', 'description': 'Percentage of successfully isolated pulmonary veins'}, {'measure': 'Real-time pulmonary vein isolation', 'timeFrame': '1-3 hours', 'description': 'Time from beginning of the freeze to conduction blockade (time to effect)'}, {'measure': 'Procedural safety', 'timeFrame': '1-3 hours', 'description': 'Procedure-related adverse events'}, {'measure': 'Total procedure time', 'timeFrame': '1-3 hours', 'description': 'Total procedure time defined from introduction of the transseptal sheath until removal of the transseptal sheath'}, {'measure': 'Cryoablation catheter procedure time', 'timeFrame': '1-3 hours', 'description': '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'}, {'measure': 'Total fluoroscopy time and dose', 'timeFrame': '1-3 hours', 'description': 'Total fluoroscopy time and dose defined from introduction of the transseptal sheath until removal of the transseptal sheath'}, {'measure': 'Cryoablation catheter fluoroscopy time and dose', 'timeFrame': '1-3 hours', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Paroxysmal Atrial Fibrillation', 'Persistent Atrial Fibrillation', 'Cryoablation', 'Cryosurgery', 'Mapping Catheter'], 'conditions': ['Atrial Fibrillation', 'Paroxysmal Atrial Fibrillation', 'Persistent Atrial Fibrillation', 'Arrhythmias, Cardiac', 'Cardiovascular Diseases', 'Heart Diseases']}, 'descriptionModule': {'briefSummary': '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).\n\nFurther aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years and legal capacity.\n* Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version 2016) - permanent AF excluded.\n* Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU).\n* 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).\n\nExclusion Criteria:\n\n* Indication that the vascular system is not accessible through the left or right groin.\n* Indication that a transseptal puncture cannot be performed.\n* Any previous ablation or surgery due to AF.\n* Important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients.\n* Left atrial diameter \\> 50 mm in the short axis.\n* Advanced structural heart disease including\n\n * moderate-to-severe valvular stenosis or regurgitation,\n * previous valve replacement or valve repair,\n * congenital heart disease,\n * left ventricular ejection fraction \\< 45% during sinus rhythm,\n * congestive heart failure NYHA III or IV,\n * coronary artery bypass graft surgery within the last 3 months.\n* Permanent pacemaker.\n* Pregnant women at the time of the cryoablation procedure.\n* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.\n* Participation in interventional trials for cardiovascular devices or drugs.'}, 'identificationModule': {'nctId': 'NCT04845750', 'acronym': 'RODEO-MaPS', 'briefTitle': 'The RODEO Micro Mapping Catheter in Cryoablation Procedures', 'organization': {'class': 'OTHER', 'fullName': 'afreeze GmbH'}, 'officialTitle': 'The RODEO Micro Mapping Catheter in Cryoablation Procedures - A Feasibility Study', 'orgStudyIdInfo': {'id': 'RODEO-MaPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rodeo Micro Mapping Catheter', 'description': 'Determination of pulmonary vein isoation during cryoablation procedure', 'interventionNames': ['Device: Rodeo Micro Mapping Catheter']}], 'interventions': [{'name': 'Rodeo Micro Mapping Catheter', 'type': 'DEVICE', 'description': 'The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation', 'armGroupLabels': ['Rodeo Micro Mapping Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Florian Hintringer, MD', 'role': 'CONTACT'}], 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '56564', 'city': 'Neuwied', 'state': 'Rhineland-Palatinate', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Burkhard Hügl, MD', 'role': 'CONTACT'}], 'facility': 'Marienhaus Klinikum St. Elisabeth Neuwied', 'geoPoint': {'lat': 50.4336, 'lon': 7.47057}}], 'centralContacts': [{'name': 'Andreas Kaiser, PhD', 'role': 'CONTACT', 'email': 'andreas.kaiser@afreeze.com', 'phone': '+43 (0)699 11073109'}, {'name': 'afreeze GmbH', 'role': 'CONTACT', 'email': 'clinical.research@afreeze.com', 'phone': '+43 (0)512 209012', 'phoneExt': '0'}], 'overallOfficials': [{'name': 'Florian Hintringer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Universität Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'afreeze GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Competence Center for Medical Devices GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}