Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-03-11 @ 7:36 AM
Study NCT ID:
NCT02639793
Status:
UNKNOWN
Last Update Posted:
2015-12-28
First Post:
2015-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-24', 'studyFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2015-12-22', 'lastUpdatePostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free of atrial fibrillation', 'timeFrame': '24 months', 'description': 'the proportion of patients remaining free from AF, atrial flutter (AFL) or atrial tachycardia (AT) (\\> 2 minutes) recorded by the implantable cardiac monitor (ICM, Reveal, Medtronic Co.) at 24 months.'}], 'secondaryOutcomes': [{'measure': 'Total AF burden', 'timeFrame': '24 months', 'description': 'total AF burden recorded by the implantable loop recorder during the 24 month follow-up.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 months', 'description': 'Safety is one of the secondary endpoints. The following potential adverse events will be monitored: Any previous left atrial ablation or surgery Any cardiac surgery or percutaneous coronary intervention within three months prior to enrolment.\n\nSecondary AF Stroke or transient ischemic attack within six months prior to enrolment Myocardial infarction within three months prior to enrolment Left ventricular ejection fraction \\< 40 % Anteroposterior left atrial diameter \\>55 mm by transthoracic or transesophageal echocardiography Implanted prosthetic valve'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arrhythmias, quality of life'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.oulu.fi/yliopisto', 'label': 'wep-page'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the atrial fibrillation burden recorded By implantable loop recorder at 12 and 24 months compared to baseline. The patients with clinical indication fo catheter ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and cryoablation.', 'detailedDescription': 'A total of 300 patients will be randomized to three different catheter ablation techniques (100 patients/group); radiofrequency ablation using remote magnet navigation, radiofrequency ablation using manual method, and cryoablation. A loop recorder (REVEAL) is implanted one month before the catheter ablation of paroxysmal atrial fibrillation and the effects of atrial fibrillation burden will be compared between the three methods at 12 and 24 months after ablation excluding the first three months´ blanking period.\n\nThe primary endpoints are:\n\n1. the proportion of patients remaining free from atrial fibrillation, atrial flutter or atrial tachycardia (\\> 2 minutes) recorded by the implantable cardiac monitor (Medtronic) at 24 months follow-up and\n2. total atrial fibrillation burden recorded by the loop recorder.\n\nOther endpoints:\n\n1. Atrial fibrillation burden in 7 days Holter recording at 12 and 24 months compared to baseline,\n2. the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation\n3. prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation\n4. re-ablation after the index ablation procedure,\n5. total procedural duration;\n6. total time of fluoroscopy and radiation dose;\n7. number and duration of cardiovascular hospitalization;\n8. quality of life questionnaires at 12 months and 24 month compared with baseline,\n9. cognitive function at 12 and 24 month compared with baseline,\n10. cost-efficacy of the different ablation techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation\n\nExclusion Criteria:\n\n\\- Any contraindication to catheter ablation'}, 'identificationModule': {'nctId': 'NCT02639793', 'acronym': 'MRICEMAN', 'briefTitle': 'Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN)', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor', 'orgStudyIdInfo': {'id': 'AFOulu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'manual radiofrequency ablation', 'description': 'Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique.', 'interventionNames': ['Procedure: catheter ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'magnet navigation ablation', 'description': 'Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique.', 'interventionNames': ['Procedure: catheter ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cryoablation', 'description': 'Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation.', 'interventionNames': ['Procedure: catheter ablation']}], 'interventions': [{'name': 'catheter ablation', 'type': 'PROCEDURE', 'description': 'Three different catheter ablation techniques will be used aimed at isolating the pulmonary veins from left atrium.The endpoint is defined as absence or dissociation of all pulmonary vein potentials as confirmed by the circular mapping catheter after a waiting period of 30 minutes after the last ablation. The use of adenosine or isoproterenol to detect concealed pulmonary vein conduction is voluntary.', 'armGroupLabels': ['cryoablation', 'magnet navigation ablation', 'manual radiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90014', 'city': 'Oulu', 'country': 'Finland', 'contacts': [{'name': 'Heikki Huikuri, Prof', 'role': 'CONTACT', 'email': 'heikki.huikuri@oulu.fi', 'phone': '+35883155599'}, {'name': 'Pekka Raatikainen, prof', 'role': 'CONTACT', 'email': 'pekka.raatikainen@hus.fi', 'phone': '+3588400892330'}], 'facility': 'UOulu', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Oulu', 'country': 'Finland', 'contacts': [{'name': 'Heikki Huikuri, Prof', 'role': 'CONTACT', 'email': 'heikki.huikuri@oiulu.fi', 'phone': '+35883154108'}], 'facility': 'Heikki Huikuri', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'centralContacts': [{'name': 'Heikki Huikuri, Prof', 'role': 'CONTACT', 'email': 'heikki.huikuri@oulu.fi', 'phone': '+358400892330'}, {'name': 'Pekka Raatikainen, Prof', 'role': 'CONTACT', 'email': 'pekka-raatikainen@hus.fi', 'phone': '+35883154108'}], 'overallOfficials': [{'name': 'Heikki Huikuri, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oulu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heikki Huikuri', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Heikki Huikuri', 'investigatorAffiliation': 'University of Oulu'}}}}