Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-05 @ 3:47 AM
Study NCT ID:
NCT03242694
Status:
UNKNOWN
Last Update Posted:
2017-08-08
First Post:
2017-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D002921', 'term': 'Cicatrix'}], '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'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005355', 'term': 'Fibrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'venous blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one-year success of pulmonary vein isolation', 'timeFrame': '3-12 months after the first pulmonary vein isolation', 'description': 'one-year success without recurrent atrial fibrillation or atrial tachycardia without antiarrhythmic drugs after the three-month blanking period of pulmonary vein isolation'}], 'secondaryOutcomes': [{'measure': 'acute unsuccessful pulmonary vein isolation', 'timeFrame': 'within 5 minutes after the last application is performed at the ablation procedure', 'description': 'operator is unable to disconnect pulmonary veins from the left atrium'}, {'measure': 'usage of antiarrhythmic drugs after the three-month blanking period', 'timeFrame': '3-12 months after the first pulmonary vein isolation', 'description': 'antiarrhythmic drugs: sotalol, amiodarone, propafenon'}, {'measure': 'reablation', 'timeFrame': '3-12 months after the first pulmonary vein isolation', 'description': 'repeated left atrial ablation is performed due to atrial fibrillation or left atrial tachycardia recurrence'}, {'measure': 'major complications of pulmonary vein isolation', 'timeFrame': 'through 1 year follow-up after the first pulmonary vein isolation', 'description': 'major complications: requiring surgical intervention or causing prolonged hospitalisation'}, {'measure': 'MACE', 'timeFrame': 'through 1 year follow-up after the first pulmonary vein isolation', 'description': 'major adverse cardiac events'}, {'measure': 'death', 'timeFrame': 'through 1 year follow-up after the first pulmonary vein isolation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['persistent atrial fibrillation', 'pulmonary vein isolation', 'catheter ablation', 'left atrial function', 'left atrial pressure', 'voltage map', 'strain', 'scar', 'success', 'biomarker'], 'conditions': ['Persistent Atrial Fibrillation', 'Catheter Ablation']}, 'descriptionModule': {'briefSummary': 'This prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). These factors - described as left atrial (LA) function - are simultaneously studied by multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous measurements are conducted before the PVI in AF and after the sinus rhythm converted due to PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples. During the one year follow-up period rhythm monitoring is conducted by regular Holter-monitoring. Our aim is to define the predictive values of the above mentioned factors and to create a new score system for predicting PVI success in persistent AF population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with persistent atrial fibrillation referred for pulmonary vein isolation at Heart and Vascular Center of Semmelweis University, Budapest, Hungary.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented, symptomatic persistent atrial fibrillation (AF)\n* catheter ablation is indicated\n* aged 18-75 years\n* signed Patient Informed Consent Form\n* able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* secondary AF\n* paroxysmal, long-standing persistent or permanent AF\n* ejection fraction \\< 30%\n* GFR \\<30 ml/min/1.73m2\n* unstable angina pectoris or myocardial infarction within the past 2 months\n* severe heart failure (NYHA IV)\n* severe COPD (GOLD III-IV)\n* previous left atrial catheter ablation\n* previous transthoracic cardiac surgery\n* implanted cardiac device (pacemaker, ICD, CRT, VAD)\n* awaiting cardiac transplantation or other cardiac surgery within the next 12 months\n* any contraindication for pulmonary vein isolation, MRI or anticoagulation\n* coagulopathy\n* active malignancy, left atrial myxoma\n* autoimmune disorder, chronic inflammatory disease\n* acute illness, active systemic infection, sepsis\n* women who are pregnant, breast feeding, or planning to become pregnant in the next 12 months\n* aged under 18 years or above 75 years\n* enrollment in other studies, which exclude participation in other studies\n* patient not willing or not able to sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT03242694', 'acronym': 'LAMPP', 'briefTitle': 'Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University Heart and Vascular Center'}, 'officialTitle': 'Left Atrial Function Analysis With Multimodal Techniques for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation', 'orgStudyIdInfo': {'id': 'LAMPP 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'persistent atrial fibrillation', 'description': 'invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm', 'interventionNames': ['Diagnostic Test: LA pressure, voltage map, strain, scar-map, blood sampling', 'Procedure: pulmonary vein isolation']}], 'interventions': [{'name': 'LA pressure, voltage map, strain, scar-map, blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm', 'armGroupLabels': ['persistent atrial fibrillation']}, {'name': 'pulmonary vein isolation', 'type': 'PROCEDURE', 'description': 'pulmonary vein isolation without creating additional ablation lesions', 'armGroupLabels': ['persistent atrial fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1122', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Peter Perge, MD', 'role': 'CONTACT', 'email': 'perge.peter@med.semmelweis-univ.hu', 'phone': '0036208259612'}], 'facility': 'Heart and Vascular Center of Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Szilvia Herczeg, MD', 'role': 'CONTACT', 'email': 'herczeg.szilvia@med.semmelweis-univ.hu', 'phone': '0036206663198'}, {'name': 'Nandor Szegedi, MD', 'role': 'CONTACT', 'email': 'szegedi.nandor@med.semmelweis-univ.hu', 'phone': '0036206663442'}], 'overallOfficials': [{'name': 'Laszlo Geller, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart and Vascular Center of Semmelweis University'}, {'name': 'Bela Merkely, MD PhD DSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Heart and Vascular Center of Semmelweis University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University Heart and Vascular Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}