Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
2019年6月19日 更新者：Medtronic Cardiac Rhythm and Heart Failure
The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm versus nominal programming.
The comparison will be performed during rest, atrial pacing and sub-maximal exercise.
AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being conducted in Europe.
調査の概要
詳細な説明
Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.
研究の種類
介入
入学 (実際)
12
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subject is age 18 or greater
- Subject is willing to sign and date the study Informed Consent form
- Subject has been implanted with a clinically indicated CRT-D device (Medtronic Vision 3D or Protecta models) for at least 1 month but less than 7 months from the date of study enrollment
Exclusion Criteria:
- Subject has a history of persistent or permanent AF for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted.
- Subject has atrial or ventricular tachyarrhythmias or frequent atrial or ventricular ectopy at the time of enrollment.
- Subject's resting heart rate at the time of enrollment exceeds 90 bpm.
- Subject had CRT system implanted for more than 7 months from the date of the study enrollment
- Subject has complete AV block.
- Subject had previous mechanical valve surgeries.
- Subject has congenital heart disease.
- Subject has contraindication for an exercise test.
- Subject is unable to perform a sub-maximal exercise test.
- It is not possible to acquire technically acceptable echocardiographic images.
- Subject has medical conditions that would limit study participation.
- Subject is pregnant (all women of child-bearing potential must undergo a pregnancy test within seven days prior to the study visit).
- Subject is enrolled in the Adaptive CRT study
- Subject is enrolled in concurrent studies which could confound the results of this study.
- Subject meets exclusion criteria required by local law
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし
- 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 |
|---|---|
|
実験的：CRT pacing at rest and during exercise
Rest and sub-maximal exercise
|
CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise
|
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 |
|---|---|---|
|
Stroke Volume at Rest
時間枠：Test day visit (within 14 days of enrollment)
|
Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.
Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart.
Stroke volume is the volume of blood pumped from a ventricle in one heart beat.
|
Test day visit (within 14 days of enrollment)
|
|
Stroke Volume During Atrial Pacing.
時間枠：Test day visit (within 14 days of enrollment)
|
Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing.
Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.
|
Test day visit (within 14 days of enrollment)
|
|
Stroke Volume During Sub-maximal Exercise.
時間枠：Test day visit (within 14 days of enrollment)
|
Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.
Sub-maximal exercise is exercise performed at a level below maximum effort.
The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.
|
Test day visit (within 14 days of enrollment)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiac Function With aCRT Settings at Rest
時間枠：Test day visit (within 14 days of enrollment)
|
Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.
|
Test day visit (within 14 days of enrollment)
|
|
Cardiac Function With Nominal Settings at Rest.
時間枠：Test day visit (within 14 days of enrollment)
|
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.
|
Test day visit (within 14 days of enrollment)
|
|
Cardiac Function With aCRT Settings During Sub-maximal Exercise.
時間枠：Test day visit (within 14 days of enrollment)
|
Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.
|
Test day visit (within 14 days of enrollment)
|
|
Cardiac Function With Nominal Settings During Sub-maximal Exercise.
時間枠：Test day visit (within 14 days of enrollment)
|
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.
|
Test day visit (within 14 days of enrollment)
|
|
Electrical Conduction at Rest.
時間枠：Test day visit (within 14 days of enrollment)
|
Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval.
The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.
|
Test day visit (within 14 days of enrollment)
|
|
Electrical Conduction During Sub-maximal Exercise.
時間枠：Time Frame: Test day visit (within 14 days of enrollment)
|
Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.
|
Time Frame: Test day visit (within 14 days of enrollment)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：AdOPT CRT/aCRT Study Team、Medtronic
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2011年11月1日
一次修了 (実際)
2012年3月1日
研究の完了 (実際)
2012年3月1日
試験登録日
最初に提出
2011年11月16日
QC基準を満たした最初の提出物
2011年11月18日
最初の投稿 (見積もり)
2011年11月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月5日
QC基準を満たした最後の更新が送信されました
2019年6月19日
最終確認日
2019年6月1日
詳しくは
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。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)