Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-02-27 @ 10:01 AM
Study NCT ID:
NCT03932604
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2019-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Sensing Capability for Better Detection of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart 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': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are randomly assigned as atrial sensing ON or Off mode'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 640}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2019-04-28', 'studyFirstSubmitQcDate': '2019-04-28', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': 'from enrollment to last follow-up (2 years)', 'description': 'cardiac implantable electronic device-detected or clinical atrial fibrillation'}, {'measure': 'Inappropriate device therapy', 'timeFrame': 'from enrollment to last follow-up (2 years)', 'description': 'inappropriate ATP or shock'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with complications associated with atrial fibrillation', 'timeFrame': 'from enrollment to last follow-up (2 years)', 'description': 'thromboembolic events, heart failure'}, {'measure': 'Number of Participants with ventricular arrhythmia', 'timeFrame': 'from enrollment to last follow-up (2 years)', 'description': 'cardiac implantable electronic device-detected or clinical ventricular arrhythmia'}, {'measure': 'Number of Participants with major adverse composite events', 'timeFrame': 'from enrollment to last follow-up (2 years)', 'description': 'cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure'}, {'measure': 'atrial lead sensing stability', 'timeFrame': 'from enrollment to last follow-up (2 years)', 'description': 'Atrioventricular synchrony ratio'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Implantable Cardioverter Defibrillator', 'Atrial Fibrillation', 'Cardiac Event', 'Cardiac Arrhythmia']}, 'referencesModule': {'references': [{'pmid': '35568193', 'type': 'DERIVED', 'citation': 'Gwag HB, Kim HR, Park SJ, Kim J, Chung TW, Choi JH, Kim JY, Park KM, On YK, Kim JS. The efficacy of single-lead implantable cardioverter-defibrillator with atrial sensing dipole to detect atrial fibrillation and to reduce inappropriate therapy according to atrial sensing ON or OFF: Rationale and design of the SMART-CONTROL study, a prospective multicenter randomized trial. Am Heart J. 2022 Sep;251:25-31. doi: 10.1016/j.ahj.2022.05.008. Epub 2022 May 12.'}]}, 'descriptionModule': {'briefSummary': 'This prospective multi-center randomized controlled study aims to compare atrial fibrillation detection and inappropriate therapy according to activation of atrial sensing capability in patients with implantable cardioverter defibrillator.', 'detailedDescription': "Implantable cardioverter defibrillators(ICD) therapy has been shown to reduce sudden cardiac death and improve survival in cardiac arrest survivors as well as in heart failure patients with left ventricular dysfunction.\n\nAtrial fibrillation (AF) is commonly found in ICD implantation patients up to 50%. AF is an independent predictor of mortality, inappropriate shock, and embolic events. Therefore, early detection of AF in patients with ICD is essential for improving the quality of life and overall prognosis of the patients.\n\nConventional ICDs consist of a single chamber (SC) ICD with a lead only in the right ventricle (RV) and dual chamber (DC) ICD with each lead in the right atrium (RA) and RV. SC ICD has the advantage of shorter procedure time, lower cost compared to DC ICD. In contrast, DC ICD has the advantage of being able to monitor atrial arrhythmic events, but complication rates were higher and additional cost and longer procedure time are usually required than SC ICD. Sixty percent of ICD implantation patients who have are SC ICD Recently, a unique ICD lead with atrial sensing ring capable of monitoring the atrial electrical signals has been developed \\[Intica 7 VR-T DX ICD (Biotronik., Germany)\\]. Therefore, turning off the atrial sensing function makes it functionally the same as SC ICD whereas turning on makes it function similar to DC ICD without additional cost and procedure time.\n\nTherefore, Detection of AF could be made earlier with VDD ICD versus conventional SC ICD without atrial sensing capability, providing a better chance to improve the prognosis of ICD patients. However, no study exists which shows whether VDD ICD is better for detecting atrial tachyarrhythmia than conventional SC ICD. Therefore, we designed a multicenter prospective randomized study comparing the AF diagnostic efficacy of VDD ICD (with atrial sensing 'ON') against conventional SC ICD. As the second phase, we also plan to compare inappropriate therapy rate according to atrial sensing status of VDD ICD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age ≥ 19 years\n2. indication for ICD implantation according to guidelines\n3. atrial fibrillation didn't detect by electrocardiogram or Holter test within the past 1 year from the ICD implantation, and\n4. CHA2DS2VASc score ≥1 point in male or ≥ 2 in female\n\nExclusion Criteria:\n\n1. persistent or permanent atrial fibrillation (AF)\n2. atrial fibrillation detected by electrocardiogram or Holter test within the past 1 year from the ICD implantation\n3. history of the catheter or surgical ablation of AF or taking antiarrhythmic drug\n4. scheduled to undergo heart transplant within 1 year\n5. life expectancy \\< 1 year\n6. requiring atrial pacing"}, 'identificationModule': {'nctId': 'NCT03932604', 'briefTitle': 'Atrial Sensing Capability for Better Detection of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Controlled Trial Comparing Atrial Sensing ON-mode of VDD Implantable Cardioverter Defibrillator(ICD) to Atrial Sensing OFF-mode of VDD ICD in Detecting Atrial Fibrillation(Smart-Control Study)', 'orgStudyIdInfo': {'id': 'SMC-2019-01-149-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Atrial sensing OFF mode', 'description': 'VDD-ICD programmed as atrial sensing Off mode'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atrial sensing ON mode', 'description': 'VDD-ICD programmed as atrial sensing ON mode', 'interventionNames': ['Device: Atrial sensing On mode']}], 'interventions': [{'name': 'Atrial sensing On mode', 'type': 'DEVICE', 'description': 'Single lead VDD-ICD programmed as atrial sensing On mode.', 'armGroupLabels': ['Atrial sensing ON mode']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Weon Park', 'role': 'CONTACT'}], 'facility': 'Sejong General Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dae Kyeong Kim', 'role': 'CONTACT'}], 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Changwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hye Bin Gwag', 'role': 'CONTACT'}], 'facility': 'Samsung Changwon Medical Center', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Cheongju-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dae In lee', 'role': 'CONTACT'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kwang Jin Chun', 'role': 'CONTACT'}], 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Soo Lee', 'role': 'CONTACT'}], 'facility': 'Daegu Catholic University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jongmin Hwang', 'role': 'CONTACT'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung Hwan Bae', 'role': 'CONTACT'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Gu Shin', 'role': 'CONTACT'}], 'facility': 'Yeongnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Minsu Kim', 'role': 'CONTACT'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Yong You', 'role': 'CONTACT'}], 'facility': 'GangNeung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Goyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hanchul Lee', 'role': 'CONTACT'}], 'facility': 'National Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yae Min Park', 'role': 'CONTACT'}], 'facility': 'Gachon University, Donginchoen Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dae Hyeok Kim', 'role': 'CONTACT'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Hyeok Kim', 'role': 'CONTACT'}], 'facility': 'Mediplex Sejong Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Il Im', 'role': 'CONTACT'}], 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jinhee Ahn', 'role': 'CONTACT'}], 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Il-young Oh', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong Geum Shin', 'role': 'CONTACT'}], 'facility': 'Hallym University Medical Center-Kangnam', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Ho Lee', 'role': 'CONTACT'}], 'facility': 'Kangbuk Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Young Roh', 'role': 'CONTACT'}], 'facility': 'Koera University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Bae Kim', 'role': 'CONTACT'}], 'facility': 'Kyung Hee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo-Hyun Lim', 'role': 'CONTACT'}], 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myung-jin Cha', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-Hwan Kim', 'role': 'CONTACT'}], 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Kyung Hwang', 'role': 'CONTACT'}], 'facility': 'VHS Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Gyo-Seung Hwang', 'role': 'CONTACT'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'You mi Hwang', 'role': 'CONTACT'}], 'facility': "The Catholic University of Korea, St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Seung-Jung Park, PhD', 'role': 'CONTACT', 'email': 'orthovics@gmail.com', 'phone': '+82-2-3410-7145'}], 'overallOfficials': [{'name': 'Seung-Jung Park, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}