Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-01-22 @ 8:03 AM
Study NCT ID:
NCT02355106
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001282', 'term': 'Atrial Flutter'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-30', 'lastUpdatePostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure.', 'timeFrame': '30 DAYS'}], 'secondaryOutcomes': [{'measure': 'Acute Success measured by Percentage of subjects with termination of AFl and complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus at the end of the ablation procedure.', 'timeFrame': '30 minutes'}, {'measure': 'Outcome success', 'timeFrame': '30 days', 'description': 'Percent of subjects with absence of AFl at 30 days (30 day ECG and as reported by subject or holter monitor)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Flutter']}, 'referencesModule': {'references': [{'pmid': '34196991', 'type': 'DERIVED', 'citation': 'Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Two symptomatic episodes of typical AFl (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFl occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFl tachyarrhythmia, including atrial fibrillation (AF).\n* At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG) within 6 months prior to enrollment.\n* Subject has been diagnosed with symptomatic AFl\n* Subject is at least 18 and ≤75 years of age.\n* Subject is able and willing to give informed consent\n\nExclusion Criteria:\n\n* Intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4 weeks of therapeutic anticoagulation and a TEE (trans-esophageal echocardiogram) and/or CT did not conclusively rule out thrombus\n* Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration \\>7 days).\n\nSubject had any previous left atrial ablation.\n\n* Subject had any previous cardiac surgery, e.g. prosthetic valves, except in the case of an isolated coronary bypass surgery performed more than three months prior to the procedure.\n* Subject has permanent pacemaker or defibrillator implant.\n* Subject has 2° type II, 3° degree atrioventricular (AV) block or left/right bundle branch block pattern\n* Subject has unstable angina pectoris.\n* Subject has history of previous myocardial infarction (MI) or percutaneous intervention during the last three months or planned in the next 3 months.\n\nSubject has symptomatic carotid stenosis.\n\n* Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.\n* Subject has any contraindication for oral anticoagulation.\n* Subject has any history of previous transient ischemic attack (TIA) or stroke.\n* Subject has known intra-cardiac thrombus formation.\n* Subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).\n* Subject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus rhythm.\n* Subject has hypertrophic cardiomyopathy.\n* Subject has abnormal long or short QT interval, signs of Brugada syndrome, known inheriting ion channel disease on the family, arrhythmogenic right ventricular dysplasia.\n* Subject has sarcoidosis.\n* Subject has myxoma.\n* Subject has thrombocytosis (platelet count \\> 600,000 / μl) or thrombocytopenia (platelet count \\<100,000 / μl).\n* Subject has any untreated or uncontrolled hyperthyroidism or hypothyroidism.\n* Subject has renal dysfunction with glomerular filtration rate \\< 60 ml/min/1.72m2.\n* Subject has a reversible causes for AF like alcoholism.\n* Subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception \\[oral contraception or intra-uterine device\\] (who must have a negative pregnancy test within 1 week of randomization) or sterile woman can be enrolled.\n* Subject is a breastfeeding woman.\n* Subject has an active systemic infection.\n* Subject is unwilling or unable to comply fully with study procedures and follow-up due to any disease condition, which can raise doubt about compliance and influencing the study outcome especially any kind of cancer requiring ongoing in-hospital treatment, severe bleeding in history or a suspected pro-coagulant state.\n* Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.\n* Subject has a life expectancy of ≤ 1 year.\n* Subject is participating in any other clinical study'}, 'identificationModule': {'nctId': 'NCT02355106', 'briefTitle': 'Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adagio Medical'}, 'officialTitle': 'A Prospective, Multicenter, Investigation of the Adagio PolarStar System in Subjects With Atrial Flutter', 'orgStudyIdInfo': {'id': 'CS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Atrial flutter Ablation', 'interventionNames': ['Device: PolarStart System']}], 'interventions': [{'name': 'PolarStart System', 'type': 'DEVICE', 'description': 'Atrial flutter Ablation', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Hospital', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adagio Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}