Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO)
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO): a Vanguard Study
This study looks at participants who have undergone an ablation procedure for atrial fibrillation previously, and atrial fibrillation has occurred and a second ablation procedure is needed. The study will randomize participants to either a tailored strategy for ablation or to widening the pulmonary vein isolation procedure with or without cavotricuspid isthmus ablation. The goal is to improve freedom from recurrent atrial arrhythmias at 12 months.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a study of patients who have undergone an ablation procedure for AF but in whom AF recurred and who are undergoing a second ablation procedure. Specifically, the investigators are interested in the group of patients whose PVs are still "isolated" during that second procedure because doctors are unsure of how best to ablate them. It is even possible that doing any more ablation in those patients is harmful.
The study will compare (1) an ablation strategy that includes commonly done ablation steps that tackle abnormalities found during the procedure (i.e., ablating "low voltage areas", searching for and ablating other arrhythmias called supraventricular tachycardias, and in some patients ablating the "posterior wall") to (2) an ablation strategy that reinforces or extends the PVI step only. In both groups, cavotricuspid isthmus ablation is also performed, if not already successfully done previously. The vanguard study will follow participants for 1 year, with a 3 year follow up planned if feasibility is met. Participants will be required to wear a Holter monitor at various timepoints and will be asked to complete atrial fibrillation and quality of life questionnaires.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tammy Knight
- Número de teléfono: 613-696-7000
- Correo electrónico: TKnight@ottawaheart.ca
Ubicaciones de estudio
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Ontario
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Ottawa, Ontario, Canadá, K1Y 4W7
- University of Ottawa Heart Institute
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Sub-Investigador:
- David Birnie, MD
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Contacto:
- Tammy Knight
- Número de teléfono: 613-696-7000
- Correo electrónico: tknight@ottawaheart.ca
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Investigador principal:
- F. Daniel Ramirez, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Paroxysmal atrial fibrillation with durable pulmonary vein isolation (PVI)
- Age >/= 18 years
- at least one episode of atrial fibrillation documented on 12-lead ECG, Holter monitor, or loop recorder in the preceding 12 months
- ability to provide informed consent
Exclusion Criteria:
- Persistent atrial fibrillation
- documented sustained atrial tachycardia or atypical atrial flutter.
- Previous atrial ablation excluding PVI or cavotricuspid Isthmus (CTI) ablation (having undergoing more than one procedure is acceptable as long as only PVI +/- CTI ablation was preformed)
- previous left atrial surgery
- known PV stenosis or history of PV intervention
- active intracardiac thrombus
- contraindication to systemic anticoagulation
- hypertrophic cardiomyopathy
- significant left-sided valve disease (moderate or severe mitral or aortic stenosis or regurgitation)
- significant congenital heart disease, including atrial septal defects or PV abnormalities (patent foramen ovale is not an exclusion)
- active pregnancy
- participation or anticipated participation in another clinical trial that could affect the results of this trial
- unwillingness or inability to adhere fully with study procedures and follow up
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Tailored Strategy
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously). |
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously). |
|
Otro: Control Strategy
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously. |
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Freedom from recurrent atrial arrhythmia lasting >/= 30 seconds
Periodo de tiempo: Days 57 to 365 from repeat procedure.
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Atrial arrhythmias include atrial fibrillation, atrial flutter, or atrial tachycardia. |
Days 57 to 365 from repeat procedure.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedure duration
Periodo de tiempo: From beginning of vascular access to removal of all catheters
|
Time, in minutes, of the repeat procedure |
From beginning of vascular access to removal of all catheters
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|
Composite of major procedure-related complications
Periodo de tiempo: Baseline to 12 months
|
Procedure-related complications include embolic events, pulmonary vein stenosis, cardiac perforation, major bleeding, atrioesophageal fistula, or death) |
Baseline to 12 months
|
|
Emergency Room visits or re-hospitalizations
Periodo de tiempo: Baseline to 12 months
|
Visits and admissions related to recurrent atrial arrhythmias |
Baseline to 12 months
|
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Repeat Catheter Ablation procedure
Periodo de tiempo: Baseline to 12 months
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Occurrence of additional ablation after the study index procedure. |
Baseline to 12 months
|
|
Atrial Fibrillation Effect on Quality of Life
Periodo de tiempo: Baseline to 12 months.
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Measured by the Atrial Fibrillation Effect on Quality of Life questionnaire. Scale of 0-100, with 100 being best quality of life. |
Baseline to 12 months.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: F. Daniel Ramirez, MD, Ottawa Heart Institute Research Corporation
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20260577-01H
Información sobre medicamentos y dispositivos, documentos del estudio
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