Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT07201506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018879', 'term': 'Ventricular Premature Complexes'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety outcome: Rate of serious adverse events related to index ablation', 'timeFrame': 'Day 0-90 after procedure', 'description': 'Composite endpoint of cardiac tamponade requiring drainage, serious vascular complications requiring interventions, stroke/TIA, coronary artery injury requiring intervention, valvular injury requiring intervention, procedural atrioventricular block requiring pacemaker implantation, death after index ablation'}], 'primaryOutcomes': [{'measure': 'Total fluoroscopy time (minutes)', 'timeFrame': 'Day 0 (during procedure)', 'description': 'Total fluoroscopy time (minutes) from the start to the end of the ablation procedure of ventricular arrhythmias'}], 'secondaryOutcomes': [{'measure': 'Dose area product', 'timeFrame': 'Day 0 (during procedure)', 'description': 'Dose area product (cGy·cm²)'}, {'measure': 'Cumulative radiation dose', 'timeFrame': 'Day 0 (during procedure)', 'description': 'Cumulative radiation dose (mGy)'}, {'measure': 'Total procedure time (minutes)', 'timeFrame': 'Day 0 (during procedure)', 'description': 'Procedure start time is defined as the time of first vascular puncture (stick), and procedure end time is defined as the placement of the vascular closure suture.'}, {'measure': 'Rate of acute procedural success', 'timeFrame': 'Day 0 (during procedure)', 'description': 'Defined as a reduction of premature ventricular contraction (PVC) burden by ≥80% and/or ventricular tachycardia (VT) non-inducibility or non-inducibility of clinical VT'}, {'measure': 'Rate of sustained VT during follow-up', 'timeFrame': 'Day 0-90 after procedure', 'description': 'Any sustained ventricular tachycardia episode (lasting ≥30 seconds or requiring an intervention by implantable cardioverter defibrillator). Assessed by a 7-day Holter and/or an implanted cardiac device, if available.'}, {'measure': 'PVC reduction (%) during follow-up', 'timeFrame': 'Day 0-90 after procedure', 'description': 'Reduction of premature ventricular contraction (PVC) burden by ≥80%. Assessed by a 7-day Holter and/or an implanted cardiac device, if available.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ablation of Arrhythmias', 'Premature Ventricular Contractions', 'Ventricular Tachycardia', 'Ventricular Arrhythmia']}, 'descriptionModule': {'briefSummary': 'This study is investigating whether using ultrasound directly inside the heart during ablation of heart rhythm disorders in the ventricles can reduce radiation exposure for patients.\n\nDuring an ablation, catheters are guided through the heart to treat the abnormal electrical signals. Usually, X-ray imaging (fluoroscopy) is used to see where the catheters are, which exposes both patients and hospital staff to radiation.\n\nThe study is randomized and controlled: half of the participants will have the ablation with ultrasound inside the heart, and the other half will have the standard ablation without ultrasound during the procedure. The main goal is to compare the amount of X-ray time used during the procedure. Secondary goals are to look at safety, effectiveness, and the total procedure time.\n\nPatients with premature ventricular contractions or ventricular tachycardia can take part. A total of 70 people will be included, 35 in each group. Using ultrasound inside the heart makes it possible to see the catheters and heart structures directly, so many steps can be done without X-rays. This could make ablations safer and reduce radiation exposure.\n\nThe study is being carried out at Inselspital, Bern University Hospital, and at University Hospital Basel. All steps are standardized and data are collected carefully. The results will show whether ultrasound during ablations can significantly reduce radiation and make ablations more efficient and safer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (≥18y) undergoing a premature ventricular contraction or ventricular tachycardia ablation.\n\nExclusion Criteria:\n\n* Origin of ventricular arrhythmia with high likelihood in the right ventricular outflow tract (left-bundle-inferior axis, \\>V4 transition precordially)\n* Primary epicardial ablation planned\n* Congenital heart disease\n* Presence of a mechanical tricuspid valve prosthesis\n* Unwilling or unable to comply fully with study procedures and followup'}, 'identificationModule': {'nctId': 'NCT07201506', 'acronym': 'REAL-ICE', 'briefTitle': 'Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Real-Time Intracardiac Echocardiography for Ventricular Arrhythmia Ablation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REAL-ICE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of SOUNDSTAR® ICE Catheter', 'description': 'Use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation', 'interventionNames': ['Device: PVC and VT ablation with ICE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care: no use of SOUNDSTAR® ICE Catheter', 'description': 'Usual Care: No use of SOUNDSTAR® ICE Catheter for premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation', 'interventionNames': ['Device: PVC and VT ablation without ICE']}], 'interventions': [{'name': 'PVC and VT ablation with ICE', 'type': 'DEVICE', 'description': 'Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation with intracardiac echocardiography (ICE)', 'armGroupLabels': ['Use of SOUNDSTAR® ICE Catheter']}, {'name': 'PVC and VT ablation without ICE', 'type': 'DEVICE', 'description': 'Premature ventricular contraction (PVC) and ventricular tachycardia (VT) ablation without intracardiac echocardiography (ICE)', 'armGroupLabels': ['Usual Care: no use of SOUNDSTAR® ICE Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4013', 'city': 'Basel', 'country': 'Switzerland', 'contacts': [{'name': 'Patrick Badertscher, MD', 'role': 'CONTACT', 'email': 'patrick.badertscher@usb.ch', 'phone': '+41 61 556 58 23'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'contacts': [{'name': 'Boldizsar Kovacs, MD', 'role': 'CONTACT', 'email': 'boldizsar.kovacs@insel.ch', 'phone': '+41 31 664 03 84'}], 'facility': 'Inselspital, Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Boldizsar Kovacs, MD', 'role': 'CONTACT', 'email': 'boldizsar.kovacs@insel.ch', 'phone': '+41 31 664 03 84'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}