Améliorer les Résultats Cliniques de l'Insuffisance Cardiaque en Exploitant le Système d'Implantation de Défibrillateur pour la Stimulation de la Région de la Branche Gauche (ACHIEVED LBBAP)
Amélioration des Résultats Cliniques de l'Insuffisance Cardiaque en Exploitant le Système d'Implantation de Sonde de Défibrillation pour la Stimulation de la Zone de Branche Gauche
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Robert Stadler
- Numéro de téléphone: 763-526-0261
- E-mail: robert.stadler@medtronic.com
Lieux d'étude
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55407
- Recrutement
- Minneapolis Heart Institute Foundation
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Chercheur principal:
- John Zakaib
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Contact:
- Ellen Thomas
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.
- Subject has documented LVEF ≤ 35% within 60 days of enrollment.
- Subject meets the criteria for presence of Strauss-defined LBBB.
- Subject meets NYHA classification II or III.
- Subject is willing and able to provide written consent.
- Subject is at least 18 years of age at the time of consent.
- Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.
- The subject's medical records must be accessible by the enrolling site over the follow-up period.
Exclusion Criteria:
- Subject has documented myocardial infarction before enrollment.
- Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.
- Subject has 2nd or 3rd degree AV block.
- Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).
- Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
- Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.
- Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).
- Subject underwent valve surgery within 90 days prior to enrollment.
- Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.
- Subject is post-heart transplantation or is actively listed on the transplantation list.
- Subject is implanted with a left ventricular assist device (LVAD).
- Subject has severe renal disease.
- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.
- Subject has complex and uncorrected congenital heart disease.
- Subject has life expectancy of less than 12 months.
- Subject is pregnant or breastfeeding.
- Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Observational Treatment Arm
|
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON) ICD programmed for LBBAP |
|
Expérimental: Sequence 1
LBBAP therapy for 6 months followed by LOT-CRT for 6 months |
CRT-D programmed for LBBAP (LV lead OFF) CRT-D programmed for LOT-CRT (LBBAP + LV lead ON) |
|
Expérimental: Sequence 2
LOT-CRT for 6 months followed by LBBAP therapy for 6 months |
CRT-D programmed for LBBAP (LV lead OFF) CRT-D programmed for LOT-CRT (LBBAP + LV lead ON) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Left ventricular ejection fraction (LVEF)
Délai: Baseline, 6 months, 12 months
|
Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months). |
Baseline, 6 months, 12 months
|
|
Left ventricular end-systolic volume (LVESV)
Délai: Baseline, 6 months, 12 months
|
Change in LVESV assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months). |
Baseline, 6 months, 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Left ventricular ejection fraction (LVEF)
Délai: Baseline, 6 months
|
Change in LVEF assessed by echocardiography from baseline to 6 months |
Baseline, 6 months
|
|
Left ventricular end-systolic volume (LVESV)
Délai: Baseline, 6 months
|
Change in LVESV assessed by echocardiography from baseline to 6 months. |
Baseline, 6 months
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MDT25031
Informations sur les médicaments et les dispositifs, documents d'étude
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