Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:10 PM
Study NCT ID:
NCT07445334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018879', 'term': 'Ventricular Premature Complexes'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization will be performed using a secure, password-protected web portal (REDCap) and the allocation sequence will be blinded to investigators and participants until the participants have been deemed eligible and enrolled in the study. It will not be possible to maintain blinding after study enrollment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in premature ventricular complex burden', 'timeFrame': 'Comparison of premature ventricular complex burden at enrolment to premature ventricular complex burden 3 months post commencement of treatment', 'description': 'Change in premature ventricular complex burden as measured by multiday heart rhythm monitoring at median 3 months.'}], 'secondaryOutcomes': [{'measure': 'Premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.', 'timeFrame': 'Comparison of premature ventricular complexes burden at enrolment to premature ventricular complex burden at a median of 6 months post commencement of treatment', 'description': 'Overall premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.'}, {'measure': 'Left ventricular function', 'timeFrame': 'Prior to or at enrollment and again at 6 months post commencement of treatment', 'description': 'Effect of treatment on left ventricular function, (including left ventricular ejection fraction percentage and global longitudinal strain), as assessed by changes in transthoracic echocardiography at baseline and 6 months.'}, {'measure': 'Quality of Life score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)', 'timeFrame': 'Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment', 'description': 'Quality of Life score as measured by questionnaire Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)'}, {'measure': 'Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire', 'timeFrame': 'Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment', 'description': 'Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire'}, {'measure': 'Quality of Life score as measured by The Implanted Cardioverter-Defibrillator Concerns (ICDC) Questionnaire', 'timeFrame': 'Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment', 'description': 'Quality of Life score as measured by The Implanted Cardioverter-Defibrillator Concerns (ICDC) Questionnaire'}, {'measure': 'Quality of Life score as measured by the Depression, Anxiety and Stress Scale -21 Items (DASS-21) questionnaire', 'timeFrame': 'Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment', 'description': 'Quality of Life score as measured by the Depression, Anxiety and Stress Scale -21 Items (DASS-21) questionnaire'}, {'measure': 'Number of patients with ≥75%, ≥90%, ≥95% reduction in burden', 'timeFrame': 'Heart rhythm monitoring performed prior to/at enrollment and again at 3 months, with repeat multi-day heart rhythm monitoring at 6 and 12 months encouraged but not mandated', 'description': 'Number of patients with ≥75%, ≥90%, ≥95% reduction in burden as assessed on multi-day heart rhythm monitoring compared to pre-enrollment multi-day heart rhythm monitoring'}, {'measure': 'Adverse Events - Medical Therapy Arm', 'timeFrame': 'Assessed over the 6 months following commencement of treatment post randomization', 'description': 'Assessment and description of adverse events associated with the prescribed medical therapy'}, {'measure': 'Adverse Events - Catheter Ablation Arm', 'timeFrame': 'Assessed over the 6 months following commencement of treatment post randomization', 'description': 'Assessment and description of adverse events associated with the catheter ablation procedure'}, {'measure': 'Health service utilization', 'timeFrame': 'From commencement of treatment until 12 months post treatment', 'description': 'Incidence of cardiovascular hospital admissions or consultations occurring for each patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PVC', 'catheter ablation', 'Premature Ventricular Complexes', 'anti-arrhythmic medication', 'beta blocker'], 'conditions': ['Premature Ventricular Complexes', 'Premature Ventricular Contraction (PVC)', 'Premature Ventricular Beats']}, 'descriptionModule': {'briefSummary': 'Premature ventricular complexes (PVCs) are extra, abnormal heart beats arising from the ventricles of the heart and are the most common ventricular arrhythmia. PVCs can be treated with medication or with a procedure called catheter ablation. It is not known which provides a better cure or provides better quality of life. The purpose of this research project is to study the best way to treat PVCs by comparing the use of medication to catheter ablation to assess which approach is better at reducing symptoms and improving quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature ventricular complex burden of at least 10%, as determined by multiday (\\>24-hour) heart rhythm monitoring\n* Normal left ventricular ejection fraction\n* Aged ≥18 years.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent or comply with study requirements including study investigations and follow-up, medical adherence, completion of intervention.\n* Women who are pregnant or breast feeding.\n* Life expectancy ≤ 12 months.\n* Ventricular tachycardia (VT) that is inducible lasting 10 seconds or more; spontaneously occurring lasting 30 seconds or more or not hemodynamically tolerated); or 10 or more episodes of non-sustained ventricular tachycardia (defined as more than five sequential beats, lasting no more than 10 seconds) in 24 hours during ambulatory heart rhythm recording.\n* Structural heart disease including clinically significant coronary artery, valvular disease or clinically significant myocardial replacement.\n* Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome).\n* Responsible primary care or other responsible physician believes it is not appropriate to participate in the study or unable to complete the study procedures, e.g. concomitant illness, physical impairment or mental condition which could interfere with the conduct of the study including outcome assessments.'}, 'identificationModule': {'nctId': 'NCT07445334', 'acronym': 'CAAD-PVC', 'briefTitle': 'Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes', 'organization': {'class': 'OTHER', 'fullName': 'Western Sydney Local Health District'}, 'officialTitle': 'Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial Pilot Study', 'orgStudyIdInfo': {'id': '2025/ETH01234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Catheter ablation', 'description': 'Catheter ablation (CA) will be performed within 6 weeks of randomisation, following standard practices approved by international guidelines. Medication for PVCs may be halted one week or five half-lives prior to CA. Procedures will be performed under conscious sedation or general anesthesia. Vascular access will be obtained from the femoral vein and or artery and electrode catheters to the coronary sinus, right ventricle and/or the left ventricle (by transseptal puncture or retrograde aortic approach).\n\nAblation will be guided by a combination of standard mapping techniques, as per standard practice. Preference will be given to "activation mapping" of the PVCs (which may be stimulated by administration of intravenous isoprenaline) using a three-dimensional electroanatomic mapping system. If there is paucity of PVCs, then "pace-mapping" will be performed.\n\nEnd point of ablation will be abolition of all PVCs (with and without isoprenaline provocation) with a 30-minute waiting period.', 'interventionNames': ['Procedure: Catheter ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)', 'description': 'Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB).\n\nPatients randomised to the control arm will be managed with medical therapy alone by their usual medical practitioners. The objective of this arm is that it replicates what would constitute standard of care for patients with PVCs managed with a non-interventional approach.\n\nStandard clinical care would usually encompass patients who have symptoms and have not previously been prescribed an AAD or BB, being commenced on an AAD and/or a BB. Choice of AAD/BB will be left to primary physician however if this is deferred to the trial team, clinical protocol would suggest sotalol 80mg twice daily - a commonly medication that has both AAD and BB properties. A lower dose may be initiated by the treating physician, as clinically indicated.\n\nIf sotalol is contraindicated, an alternative BB may be initiated using standard doses e.g. metoprolol, atenolol, bisoprolol, carvedilol.', 'interventionNames': ['Drug: Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)']}], 'interventions': [{'name': 'Catheter ablation', 'type': 'PROCEDURE', 'description': 'Catheter ablation (CA) of premature ventricular complexes (PVCs) will be performed in standard fashion as approved by international guidelines. CA aims to deliver therapeutic energy to the site of origin of the PVCs, rendering the tissue there incapable of causing the arrhythmia. Ablations will be performed under sedation or GA, guided by electroanatomic mapping and cardiac imaging. End point of CA will be abolition of all PVCs (with and without isoprenaline provocation) with a 30-minute waiting period.\n\nOccasionally, patients may experience episodes of PVC quiescence and an absence of PVCs on the day of CA. This can be a result of changes in medication, stress, hormones, electrolytes and can be unpredictable. As at least one PVC occurring during the CA is required to perform a CA, an episode of PVC quiescence on the day of the procedure that inhibits the ablation from taking place will not preclude the patient from having a repeat attempt at the CA.', 'armGroupLabels': ['Catheter ablation']}, {'name': 'Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)', 'type': 'DRUG', 'description': 'This arm aims to replicate standard of care for patients with PVCs managed by a non-interventional approach, usually encompassing patients who have symptoms and have not previously been prescribed an AAD or BB, being commenced on an AAD and/or a BB. Choice of AAD/BB will be left to primary physician: If deferred to the trial team, clinical protocol suggests sotalol (which has both AAD and BB properties) 80mg twice daily, or a lower dose if indicated. If sotalol is contraindicated, an alternative BB may be initiated using standard doses (metoprolol, atenolol, bisoprolol). Clinicians may consider alternative AAD if BBs are contraindicated. For example, a dihydropyridine calcium channel blocker (verapamil or diltiazem) may be initiated if patient has concurrent asthma. If coronary artery disease and structural heart disease is ruled out, flecainide (class I anti-arrhythmic agent) may be used. As with clinical practice, AAD/BB can be changed at any time depending on clinical response.', 'armGroupLabels': ['Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2017', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'contacts': [{'name': 'Saurabh Kumar, MBBS, PhD', 'role': 'CONTACT', 'email': 'saurabh.kumar@health.nsw.gov.au', 'phone': '+61288908140'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}], 'centralContacts': [{'name': 'Saurabh Kumar, MBBS, PhD', 'role': 'CONTACT', 'email': 'saurabh.kumar@health.nsw.gov.au', 'phone': '+61288908140'}, {'name': 'Sam Turnbull', 'role': 'CONTACT', 'email': 'samual.turnbull@health.nsw.gov.au'}], 'overallOfficials': [{'name': 'Saurabh Kumar, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Sydney Local Health District'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Sydney Local Health District', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Saurabh Kumar', 'investigatorAffiliation': 'Western Sydney Local Health District'}}}}