Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01276093
Status:
TERMINATED
Last Update Posted:
2015-12-30
First Post:
2011-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000638', 'term': 'Amiodarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'whyStopped': 'DSMB recommendation; enrollment too slow', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia', 'timeFrame': 'Until 1 year after post treatment blanking period'}], 'secondaryOutcomes': [{'measure': 'Composite end point of hospitalization, stroke, major bleeding and death', 'timeFrame': 'Until last patient has been followed for 15 months after inclusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'PVI ablation', 'Elderly patients', 'Efficacy'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.', 'detailedDescription': 'Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years at moment of screening, able to sign informed consent.\n* Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months.\n* Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year.\n* No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total.\n\nExclusion Criteria:\n\n* EF \\< 35 % or description of "poor left ventricular function" on echocardiogram. Measurement should not be older than 6 months at moment of screening.\n* Aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade \\>3)\n* Acute illness: unstable angina, infectious disease.\n* Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome.\n* Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia).\n* Previous ablation.\n* Contraindications for amiodarone; liver dysfunction (serum alanine aminotransferase \\>2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline QTc \\>460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rhythm); second or third degree AV-block.\n* Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamin K antagonists.\n* Any myocardial infarction or PCI in previous 6 months.\n* CABG in previous 6 months.\n* Renal dysfunction: creatinine clearance \\<45 ml/min\n* Severe co-morbidity. Life expectancy less than 1 year.\n* Thrombus in left atrium\n* Untreatable allergy to contrast media'}, 'identificationModule': {'nctId': 'NCT01276093', 'acronym': 'PAVANE', 'briefTitle': 'Pulmonary Vein Ablation Versus Amiodarone in the Elderly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Pulmonary Vein Ablation Versus Amiodarone in the Elderly', 'orgStudyIdInfo': {'id': 'AF-10-023-ND-AB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PVI ablation', 'description': 'Pulmonary Vein Ablation', 'interventionNames': ['Procedure: PVI ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amiodarone medical treatment', 'description': 'Amiodarone medical treatment', 'interventionNames': ['Drug: Amiodarone']}], 'interventions': [{'name': 'PVI ablation', 'type': 'PROCEDURE', 'otherNames': ['Pulmonary Vein Isolation'], 'description': 'Pulmonary Vein Ablation using RF.', 'armGroupLabels': ['PVI ablation']}, {'name': 'Amiodarone', 'type': 'DRUG', 'description': 'Amiodarone tablets', 'armGroupLabels': ['Amiodarone medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helmond', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Elkerliek Hospital', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'zip': '5504DB', 'city': 'Veldhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Maxima Medical Center', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'zip': '2545 CH', 'city': 'The Hague', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Haga Hospital', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwen Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '7513 ER', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}], 'overallOfficials': [{'name': 'Lukas Dekker, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catharina Ziekenhuis Eindhoven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}