Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT06496633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'We collected 10 ml of peripheral venous blood from the HCM patient and extracted the genome from the isolated white blood cells using The Relax Gene Blood DNA System (cat. no. DP319; Tiangen Biotech Co, Ltd., Beijing, China). After gene extraction, 96 cardio-disease-related genes were analyzed by an experienced genetic Counselor.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment success rate', 'timeFrame': 'Six months after procedure.', 'description': 'For survival, the left ventricular outflow tract pressure gradient (LVOT pressure gradient) decreased by ≥ 50% or the resting left ventricular outflow tract pressure gradient (LVOT pressure gradient) was \\< 30 mmHg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous Intramyocardial Septal Radiofrequency Ablation', 'Hypertrophic Cardiomyopathy', 'Alcohol Septal Ablation'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '41015247', 'type': 'DERIVED', 'citation': 'Zhang J, Hsi DH, Ta S, Wang J, Wang B, Ma H, Shan B, Hu R, Li J, Liu L. Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Cardiomyopathy With Residual Obstruction After Alcohol Septal Ablation. Can J Cardiol. 2025 Sep 25:S0828-282X(25)01051-7. doi: 10.1016/j.cjca.2025.08.355. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new minimally invasive treatment for HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery in HOCM patients who failed alcohol ablation and provide new treatment methods for patients.', 'detailedDescription': 'Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiovascular disease, mostly due to mutations in the gene encoding myocardial sarcomere contractile protein, with an incidence of about 1:500-1:200. HCM is the main cause of sudden cardiac death in young people and athletes. Its clinical manifestations are highly heterogeneous. Some patients have no obvious symptoms or mild symptoms, but some patients have obvious myocardial hypertrophy in the early stage, resulting in chest tightness, chest pain, breathing difficulties, syncope, heart failure, and even sudden cardiac death. The annual mortality rate of HCM patients is about 1.4% -2.2%. Alcohol septal ablation (ASA) is a kind of interventional therapy. Its principle is to inject anhydrous alcohol through a catheter, occlude the septal branch of the coronary artery, make the hypertrophic ventricular septal myocardium that dominates it ischemic, necrosis, thinning, and contractility decrease, so that the obstruction of the outflow tract disappears or alleviates, thereby improving the clinical symptoms of patients. However, HOCM patients often have serious clinical symptoms and adverse complications after alcohol ablation, and invasive surgical treatment is required when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new path to treat minimally invasive HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery after alcohol ablation in HOCM patients, and to verify its early postoperative efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with obstructive hypertrophic cardiomyopathy who underwent Liwen surgery at the Multidisciplinary Diagnosis and Treatment and Genetic Counseling Center for Hypertrophic Cardiomyopathy at Xijing Hospital of the Air Force Military Medical University from January 2017 to August 2023, all of whom had a history of alcohol ablation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient is at least 18 years of age.\n2. Hypertrophic cardiomyopathy with alcohol ablation, LVOT pressure difference at rest or after excitation ≥ 50mmHg;\n3. The clinical symptoms are obvious, fatigue, shortness of breath, exhaustive angina pectoris, syncope, etc. seriously affect the quality of life, and the effect of adequate drug treatment is not good or the side effects of drugs cannot be tolerated;\n4. After the informed consent of the patient and his family, he voluntarily underwent Liwen surgery.\n\nExclusion Criteria:\n\n1. Non-obstructive hypertrophic cardiomyopathy;\n2. Left ventricular hypertrophy due to secondary causes, such as increased preload, history of taking drugs suspected of causing left ventricular hypertrophy, etc.\n3. Preoperative complications with other heart diseases require surgical treatment.\n4. The disease will make it difficult to evaluate treatment (e.g. cancer, severe metabolic diseases, mental illness, etc.).\n5. Patients who have participated in any clinical trial of drugs and/or medical devices within 1 month before surgery or during follow-up;\n6. Pregnant and breastfeeding women;\n7. Patients with poor adherence may not cooperate during treatment or follow-up.'}, 'identificationModule': {'nctId': 'NCT06496633', 'acronym': 'HCM', 'briefTitle': 'Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Efficacy and Safety of Echocardiography-guided Percutaneous Intraventricular Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy After Alcohol Septal Ablation', 'orgStudyIdInfo': {'id': 'KY20242206-C-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cohort :Hypertrophic Cardiomyopathy patients with residual obstruction after Alcohol Septal Ablation', 'description': 'All patients performed procedure of Percutaneous Intramyocardial Septal Radiofrequency Ablation', 'interventionNames': ['Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation']}], 'interventions': [{'name': 'Percutaneous Intramyocardial Septal Radiofrequency Ablation', 'type': 'PROCEDURE', 'description': 'PIMSRA procedure represents a significant breakthrough in the treatment of HOCM patients, as it uses a unique transmyocardial approach to directly and precisely insert a radiofrequency electrode needle into the hypertrophied IVS for targeted ablation', 'armGroupLabels': ['cohort :Hypertrophic Cardiomyopathy patients with residual obstruction after Alcohol Septal Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Liu Liwen', 'investigatorAffiliation': 'Xijing Hospital'}}}}