BIO|MASTER.CSP スタディ
Amvia ペースメーカーと Solia CSP S ペーシングに関する重要な研究 伝導系ペーシングのリード
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Alkmaar、オランダ、1815 JD
- Noordwest Ziekenhuisgroep
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Eindhoven、オランダ、5623 EJ
- Catharina Ziekenhuis
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Adelaide、オーストラリア、5068
- Integral Healthcare
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Clayton、オーストラリア、3168
- Victorian Heart Hospital
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Elizabeth Vale、オーストラリア、5112
- Lyell McEwin Hospital
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Grafton、ニュージーランド、1023
- Auckland City Hospital
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Marseille、フランス、13005
- Hopital de la Timone (CHU La Timone)
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Metz、フランス、57038
- Centre Hospitalier Metz-Thionville
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Nantes、フランス、44277
- Hôpital privé du Confluent
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Pessac、フランス、33600
- Hôpital Haut Lévêque (CHU)
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Bruges、ベルギー、8000
- AZ Sint-Jan
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Charleroi、ベルギー、6060
- Grand Hôpital de Charleroi
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Ghent、ベルギー、9000
- UZ Gent - Universitair Ziekenhuis Gent
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Ottignies、ベルギー、1340
- Clinique Saint-Pierre Ottignies
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：LBBAP Amvia
All patients with successful implantation of Amvia pacemaker and a lead in a position intended for LBBA pacing. |
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実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Amvia related SADE-d free rate
時間枠：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
時間枠：6 months (183 days) after implantation
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Amvia related SADE-d free rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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 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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディチェア：Jan De Pooter, MD, PhD、University Hospital Ghent, Gent (Belgium)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BA113
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。