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El ensayo clínico NCT07445334 (CAAD-PVC) para Premature Ventricular Complexes, Premature Ventricular Contraction (PVC), Premature Ventricular Beats está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC) 40

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Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07445334 (CAAD-PVC) es un estudio intervencionista para Premature Ventricular Complexes, Premature Ventricular Contraction (PVC), Premature Ventricular Beats. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de marzo de 2026 hasta completar 40 participantes. Dirigido por Western Sydney Local Health District, se espera que finalice el 1 de marzo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de marzo de 2026.
Resumen
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 ...Mostrar más
Título oficial

Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial Pilot Study

Condiciones médicas
Premature Ventricular ComplexesPremature Ventricular Contraction (PVC)Premature Ventricular Beats
Otros ID del estudio
  • CAAD-PVC
  • 2025/ETH01234
Número del NCT
NCT07445334
Inicio del estudio (real)
2026-03-01
Última actualización
2026-03-03
Fecha de finalización (estimada)
2028-03-01
Inscripción (prevista)
40
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
PVC
catheter ablation
Premature Ventricular Complexes
anti-arrhythmic medication
beta blocker
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Comparador activoCatheter ablation
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 ventr...Mostrar más
Ablación con catéter
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 ...Mostrar más
Comparador activoMedical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB). Patients 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. Standard clinical care would usually encompass patient...Mostrar más
Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
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 da...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change in premature ventricular complex burden
Change in premature ventricular complex burden as measured by multiday heart rhythm monitoring at median 3 months.
Comparison of premature ventricular complex burden at enrolment to premature ventricular complex burden 3 months post commencement of treatment
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.
Overall premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.
Comparison of premature ventricular complexes burden at enrolment to premature ventricular complex burden at a median of 6 months post commencement of treatment
Left ventricular function
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.
Prior to or at enrollment and again at 6 months post commencement of treatment
Quality of Life score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)
Quality of Life score as measured by questionnaire Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)
Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire
Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire
Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Quality of Life score as measured by The Implanted Cardioverter-Defibrillator Concerns (ICDC) Questionnaire
Quality of Life score as measured by The Implanted Cardioverter-Defibrillator Concerns (ICDC) Questionnaire
Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Quality of Life score as measured by the Depression, Anxiety and Stress Scale -21 Items (DASS-21) questionnaire
Quality of Life score as measured by the Depression, Anxiety and Stress Scale -21 Items (DASS-21) questionnaire
Quality of Life questionnaire completed at enrolment and again at 6 months post commencement of treatment
Number of patients with ≥75%, ≥90%, ≥95% reduction in burden
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
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
Adverse Events - Medical Therapy Arm
Assessment and description of adverse events associated with the prescribed medical therapy
Assessed over the 6 months following commencement of treatment post randomization
Adverse Events - Catheter Ablation Arm
Assessment and description of adverse events associated with the catheter ablation procedure
Assessed over the 6 months following commencement of treatment post randomization
Health service utilization
Incidence of cardiovascular hospital admissions or consultations occurring for each patient
From commencement of treatment until 12 months post treatment
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Premature ventricular complex burden of at least 10%, as determined by multiday (>24-hour) heart rhythm monitoring
  • Normal left ventricular ejection fraction
  • Aged ≥18 years.

  • Unable or unwilling to provide informed consent or comply with study requirements including study investigations and follow-up, medical adherence, completion of intervention.
  • Women who are pregnant or breast feeding.
  • Life expectancy ≤ 12 months.
  • 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.
  • Structural heart disease including clinically significant coronary artery, valvular disease or clinically significant myocardial replacement.
  • Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome).
  • 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.
Western Sydney Local Health District logoWestern Sydney Local Health District
Parte responsable del estudio
Saurabh Kumar, Investigador principal, Associate Professor, Western Sydney Local Health District
Contactos centrales del estudio
Contacto: Saurabh Kumar, MBBS, PhD, +61288908140, [email protected]
Contacto: Sam Turnbull, [email protected]
1 Centros del estudio en 1 países

New South Wales

Westmead Hospital, Westmead, New South Wales, 2017, Australia
Saurabh Kumar, MBBS, PhD, Contacto, +61288908140, [email protected]