Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-06 @ 8:33 PM
Study NCT ID:
NCT03246594
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oesophageal complications after RF Ablation depending on using an oesophageal probe', 'timeFrame': 'Up to 6 months', 'description': 'Incidence of oesophageal mucosa alterations in gastroscopy'}], 'secondaryOutcomes': [{'measure': 'Rhythm stability after RF ablation of atrial fibrillation (AF)', 'timeFrame': '6 Months', 'description': 'Percentage of AF/AT recurrences in 7 day holter at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'esophageal probe', 'thermolesion'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '32820324', 'type': 'DERIVED', 'citation': 'Schoene K, Arya A, Grashoff F, Knopp H, Weber A, Lerche M, Konig S, Hilbert S, Kircher S, Bertagnolli L, Dinov B, Hindricks G, Halm U, Zachaus M, Sommer P. Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial. Europace. 2020 Oct 1;22(10):1487-1494. doi: 10.1093/europace/euaa209.'}]}, 'descriptionModule': {'briefSummary': 'The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation of atrial fibrillation regarding oesophageal ulcers after ablation.', 'detailedDescription': 'The Trial will evaluate the influence of oesophageal probes in RF-ablation of atrial fibrillation regarding oesophageal complications after ablation.\n\n200 patients will be prospectively randomised into 2 groups. The conventional group will undergo RF-Ablation of atrial fibrillation using an oesophageal probe to measure the temperature during ablation.\n\nIn the other group will receive ablation using fixed energy levels (25 Watt) at the posterior left atrial (LA) Wall without an oesophageal probe , All patients will get a gastroscopy for evaluation of oesophageal complications the day after the procedure.\n\nAll patients will have a 6 months follow up (FU) in our clinic to be reevaluated for complications (primary endpoint) and rhythm stability. (secondary endpoint)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12 lead ECG with documented atrial fibrillation\n* Indication for RF ablation of atrial fibrillation according to the recent guidelines\n* Signed informed consent\n* Age 18-85 years\n\nExclusion Criteria:\n\n* Pregnancy or possible pregnancy without negative test within 48h prior to ablation\n* Intracardiac thrombus\n* Contraindication for oral anticoagulation\n* Conditions, that may complicate the positioning of the oesophageal probe'}, 'identificationModule': {'nctId': 'NCT03246594', 'acronym': 'OPERA', 'briefTitle': 'Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Heart Center Leipzig - University Hospital'}, 'officialTitle': 'Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'Opera-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esophageal Probe', 'description': 'Participants in this group will receive ablation for atrial fibrillation with a oesophageal probe placed for temperature monitoring.\n\nPlacement of oesophageal probe for temperature measurement', 'interventionNames': ['Device: Placement of oesophageal probe for temperature measurement']}, {'type': 'EXPERIMENTAL', 'label': 'No Esophageal Probe', 'description': 'Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring.\n\nIntervention: Power limitation of RF generator', 'interventionNames': ['Device: Power limitation of RF generator']}], 'interventions': [{'name': 'Placement of oesophageal probe for temperature measurement', 'type': 'DEVICE', 'description': 'The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus', 'armGroupLabels': ['Esophageal Probe']}, {'name': 'Power limitation of RF generator', 'type': 'DEVICE', 'description': 'no probe utilized; Limit the RF Generator Output to 25W', 'armGroupLabels': ['No Esophageal Probe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}