Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-31 @ 12:20 AM
Study NCT ID:
NCT05107635
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inappropriate Sinus Tachycardia Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054972', 'term': 'Postural Orthostatic Tachycardia Syndrome'}], 'ancestors': [{'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AtriCure commercially available devices used to treat IST or POTS', 'timeFrame': '12 months', 'description': 'The IST Registry will attempt to enroll all eligible patients at registry sites who have already had or are scheduled to have a procedure to treat IST/POTS that includes the use of at least one commercially available AtriCure cardiac ablation devices.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Inappropriate Sinus Tachycardia', 'Postural Tachycardia Syndrome;', 'Sinus Node Sparing Hybrid Procedure'], 'conditions': ['Inappropriate Sinus Tachycardia', 'Postural Tachycardia Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). This is a retrospective and prospective, multicenter, US/OUS, observational data registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices.\n2. Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements\n\nExclusion Criteria:\n\n1. Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.\n2. Subject with exclusion criteria required by FDA or local governance"}, 'identificationModule': {'nctId': 'NCT05107635', 'briefTitle': 'Inappropriate Sinus Tachycardia Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'AtriCure, Inc.'}, 'officialTitle': 'A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment', 'orgStudyIdInfo': {'id': 'RP-2021-IST'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AtriCure Commercially Available Devices', 'type': 'DEVICE', 'description': 'Epicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany Koyano', 'role': 'CONTACT', 'email': 'tkoyano3@stanford.edu', 'phone': '650-724-6921'}, {'name': 'Anson Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94062', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Juanita Fuji', 'role': 'CONTACT', 'email': 'Juanita.fujii@commonspirit.org', 'phone': '650-482-6131'}, {'name': 'Chad Brodt', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sequoia Hospital', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Cobb', 'role': 'CONTACT', 'email': 'Jessica.cobb@surgery.ufl.edu', 'phone': '352-514-3729'}, {'name': 'Thomas Beaver', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexandra Gardner', 'role': 'CONTACT', 'email': 'Alexandra-Gardner@smh.com', 'phone': '941-917-8791'}, {'name': 'Paul Vesco', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sarasota Memorial Hospital', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'Donita.Atkins@hcahealthcare.com', 'phone': '913-934-4313'}, {'name': 'Dhanunjaya Lakkireddy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kansas City Cardiac Arrhythmia Research', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Mahoney', 'role': 'CONTACT', 'email': 'katharine.e.mahoney@medstar.net', 'phone': '202-877-2806'}, {'name': 'Thomaides Athanasios', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MedStar Health Research Institute', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Voorhorst', 'role': 'CONTACT', 'email': 'Anne.Voorhorst@thechristhospital.com', 'phone': '513-585-1777'}, {'name': 'Michael Smith', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chantel Scallon', 'role': 'CONTACT', 'email': 'cmscallon@austinheartbeat.com', 'phone': '512-807-3150'}, {'name': 'Andrea Natale', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsey Beven', 'role': 'CONTACT', 'email': 'Lindsey.Bevan@imail.org', 'phone': '801-507-4889'}, {'name': 'John Doty', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Iris Vanzeebroeck', 'role': 'CONTACT', 'email': 'iris.vanzeebroeck@uzbrussel.be', 'phone': '02/476 35 09'}, {'name': 'Carlo de Asmundis, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Ziekenhuis Brussels', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Registry Specialist', 'role': 'CONTACT', 'email': 'IST-Registry@atricure.com', 'phone': '866-349-2342'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}