Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)
19. juni 2019 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stroke Volume at Rest
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiac Function With aCRT Settings at Rest
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: AdOPT CRT/aCRT Study Team, Medtronic
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2011
Primær fullføring (Faktiske)
1. mars 2012
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
16. november 2011
Først innsendt som oppfylte QC-kriteriene
18. november 2011
Først lagt ut (Anslag)
21. november 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juni 2019
Sist bekreftet
1. juni 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AdOPT CRT Sub Study
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