Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-03-11 @ 7:00 AM
Study NCT ID:
NCT05404204
Status:
UNKNOWN
Last Update Posted:
2022-06-03
First Post:
2022-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-31', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-31', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful ventricular pacing', 'timeFrame': 'At the start of the PCI procedure immediately prior to rotational atherectomy', 'description': 'Ability to obtain successful ventricular capture prior to rotational atherectomy'}, {'measure': 'Ventricular pacing threshold', 'timeFrame': 'At the start of the PCI procedure immediately prior to rotational atherectomy', 'description': 'The pacing threshold to obtain successful ventricular capture'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'At the end of the PCI procedure', 'description': '(a) Coronary wire-related intractable spasm (unresponsive to vasodilator therapy); (b) coronary wire-related perforation; (c) New atrial or ventricular arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Calcification', 'Rotational Atherectomy', 'Temporary Pacemaker'], 'conditions': ['Coronary Artery Disease', 'Coronary Artery Calcification', 'Bradycardia']}, 'referencesModule': {'references': [{'pmid': '37409992', 'type': 'DERIVED', 'citation': 'Iqbal MB, Robinson SD, Nadra IJ, Das D, van Zyl M, Sikkel MB, Della Siega A. The Efficacy and Safety of an Adjunctive Transcoronary Pacing Strategy During Rotational Atherectomy: ROTA-PACE Study. JACC Cardiovasc Interv. 2023 Sep 11;16(17):2189-2190. doi: 10.1016/j.jcin.2023.05.022. Epub 2023 Jul 5. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing rotational atherectomy for calcific coronary disease without any exclusion criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-90 years\n* Undergoing percutaneous coronary intervention for angina or acute coronary syndrome.\n* Calcific coronary disease requiring rotational atherectomy\n\nExclusion Criteria:\n\n* Pre-existing pacemaker or implantable cardioverter defibrillator.\n* Mobitz II heart block or complete heart block.'}, 'identificationModule': {'nctId': 'NCT05404204', 'acronym': 'ROTA-PACE', 'briefTitle': 'The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy', 'organization': {'class': 'OTHER', 'fullName': 'Vancouver Island Health Authority'}, 'officialTitle': 'Strategy to ROTAblate and PACE (ROTA-PACE) Study', 'orgStudyIdInfo': {'id': 'ROTA-PACE'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V8R 1J8', 'city': 'Victoria', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Bilal Iqbal, MD PhD FRCPC', 'role': 'CONTACT', 'email': 'bilal.iqbal@viha.ca', 'phone': '2505953111'}], 'facility': 'Royal Jubilee Hospital', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}], 'centralContacts': [{'name': 'Bilal Iqbal, MD PhD FRCPC', 'role': 'CONTACT', 'email': 'bilal.iqbal@viha.ca', 'phone': '2505953111'}, {'name': 'Anthony Della Siega, MD FRCPC', 'role': 'CONTACT', 'email': 'anthony.dellasiega@viha.ca', 'phone': '2505953111'}], 'overallOfficials': [{'name': 'Bilal Iqbal, MD PhD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Jubilee Hospital, Victoria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vancouver Island Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Bilal Iqbal', 'investigatorAffiliation': 'Vancouver Island Health Authority'}}}}