Estudo BIO|MASTER.CSP
Estudo fundamental do líder de estimulação Amvia Pacemaker e Solia CSP S na estimulação do sistema de condução
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Adelaide, Austrália, 5068
- Integral Healthcare
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Clayton, Austrália, 3168
- Victorian Heart Hospital
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Elizabeth Vale, Austrália, 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, França, 13005
- Hopital de la Timone (CHU La Timone)
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Metz, França, 57038
- Centre Hospitalier Metz-Thionville
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Nantes, França, 44277
- Hôpital privé du Confluent
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Pessac, França, 33600
- Hôpital Haut Lévêque (CHU)
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Alkmaar, Holanda, 1815 JD
- Noordwest Ziekenhuisgroep
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Eindhoven, Holanda, 5623 EJ
- Catharina Ziekenhuis
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Grafton, Nova Zelândia, 1023
- Auckland City Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Amvia related SADE-d free rate
Prazo: 6 months (183 days) after implantation
|
rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker |
6 months (183 days) after implantation
|
|
Solia CSP S related SADE-d free rate
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Amvia related SADE-d free rate
Prazo: 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
|
|
Solia CSP S related SADE-d free rate
Prazo: 12 months (365 days) after implantation
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 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
Prazo: 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
|
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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Jan De Pooter, MD, PhD, University Hospital Ghent, Gent (Belgium)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BA113
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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