BIO|Estudio MASTER.CSP
Estudio fundamental del marcapasos Amvia y el cable de estimulación Solia CSP S en la estimulación del sistema de conducción
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs.
The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Adelaide, Australia, 5068
- Integral Healthcare
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Clayton, Australia, 3168
- Victorian Heart Hospital
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Elizabeth Vale, Australia, 5112
- Lyell McEwin Hospital
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Bruges, Bélgica, 8000
- AZ Sint-Jan
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Charleroi, Bélgica, 6060
- Grand Hôpital de Charleroi
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Ghent, Bélgica, 9000
- UZ Gent - Universitair Ziekenhuis Gent
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Ottignies, Bélgica, 1340
- Clinique Saint-Pierre Ottignies
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Marseille, Francia, 13005
- Hopital de la Timone (CHU La Timone)
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Metz, Francia, 57038
- Centre Hospitalier Metz-Thionville
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Nantes, Francia, 44277
- Hôpital privé du Confluent
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Pessac, Francia, 33600
- Hôpital Haut Lévêque (CHU)
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Grafton, Nueva Zelanda, 1023
- Auckland City Hospital
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Alkmaar, Países Bajos, 1815 JD
- Noordwest Ziekenhuisgroep
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Eindhoven, Países Bajos, 5623 EJ
- Catharina Ziekenhuis
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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:
For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment:
- Standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (CRT)
- Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch area stimulation
- Ability to understand the nature of the study
- Ability and willingness to perform all follow-up visits at the study site
- Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
Exclusion Criteria:
Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled:
- Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- Expected to receive heart transplantation or ventricular assist device within 12 months
- Life-expectancy less than 12 months
- Pregnant or breast feeding
- Age less than 18 years
- Participation in another interventional clinical investigation (according to the definition given in the CIP)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: LBBAP Amvia
All patients with successful implantation of Amvia pacemaker and a lead in a position intended for LBBA pacing. |
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Experimental: LBBAP Solia CSP S
All patients with successful implantation of a Solia CSP S lead in LBB area. Additionally, all patients with a non-successful Solia CSP S implantation attempt in which an ADE (adverse device effect) or SADE (serious adverse device effect) related to the Solia CSP S lead occurred. |
Left bundle branch area pacing using a Solia CSP S lead |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Amvia related SADE-d free rate
Periodo de tiempo: 6 months (183 days) after implantation
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rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker |
6 months (183 days) after implantation
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Solia CSP S related SADE-d free rate
Periodo de tiempo: 6 months (183 days) after implantation
|
rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead |
6 months (183 days) after implantation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Amvia related SADE-d free rate
Periodo de tiempo: 12 months (365 days) after implantation
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Rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker |
12 months (365 days) after implantation
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Solia CSP S related SADE-d free rate
Periodo de tiempo: 12 months (365 days) after implantation
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Rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead |
12 months (365 days) after implantation
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Rate of successful acute CSP implantation of Solia CSP S
Periodo de tiempo: At the day of implantation
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All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently in the conduction system, are counted as acute success. |
At the day of implantation
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Sensing performance
Periodo de tiempo: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
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Investigators will be asked whether the sensing is adequate (yes/no decision) |
At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
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Pacing performance
Periodo de tiempo: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
|
Investigators will be asked whether the pacing is adequate (yes/no decision) |
At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
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Physiologic ventricular excitation
Periodo de tiempo: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
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Investigators are asked to assess whether pacing in the left bundle branch area is still present based on the 12-lead ECG recording |
At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
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Mid-term change in LVEF
Periodo de tiempo: At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
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Collection of left ventricular ejection fraction (LVEF) values |
At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
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Mid-term change in LVESV
Periodo de tiempo: At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
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Collection of left ventricular ejection systolic volume (LVESV) values |
At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
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Mid-term change in quality of life, EQ-5D-5L (EuroQol) questionnaire
Periodo de tiempo: At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
|
Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to EuroQol methodology |
At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
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Mid-term change in quality of life, SF-36 (Short Form Health Survey) questionnaire
Periodo de tiempo: At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
|
Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to item short form health survey (SF-36) standard methodology |
At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Jan De Pooter, MD, PhD, University Hospital Ghent, Gent (Belgium)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BA113
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Anonymized data may be shared with qualified healthcare practitioners or academic researchers upon request and with permission of BIOTRONIK. Requests shall be sent to the Clinical Research Department of BIOTRONIK.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .