Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
19 juin 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.
Type d'étude
Interventionnel
Inscription (Réel)
12
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Stroke Volume at Rest
Délai: 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.
Délai: 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.
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiac Function With aCRT Settings at Rest
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: AdOPT CRT/aCRT Study Team, Medtronic
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 novembre 2011
Achèvement primaire (Réel)
1 mars 2012
Achèvement de l'étude (Réel)
1 mars 2012
Dates d'inscription aux études
Première soumission
16 novembre 2011
Première soumission répondant aux critères de contrôle qualité
18 novembre 2011
Première publication (Estimation)
21 novembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AdOPT CRT Sub Study
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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