Mitral Insufficiency Reduction With Biventricular Pacing (MiRBi)
1. desember 2010 oppdatert av: Trinity Medical Center, Illinois
Prospective.Randomized, Blinded, Crossover Chronic IDE Study of the Effects of Pacing on Mitral Regurgitation in Patients Without Standard Indications for Cardiac Resynchronization Therapy
The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these patients.
Studieoversikt
Detaljert beskrivelse
Approximately 50 patients will be randomized, followed and analyzed in this prospective study.
Patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a CRT system.
Baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant.
The baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting.
Repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period.
Studietype
Intervensjonell
Registrering (Forventet)
50
Fase
- Fase 1
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:
- Patient is at least 18 years of age
Patients with moderate-to-severe or severe functional MR.
- EROA > 40 mm2 and an MR/LA > 40% (severe)
- 30 ≤ EROA ≤ 40 mm2 and 30 ≤ MR/LA ≤ 40% (moderate-to-severe)
- Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF
- QRS < 120 ms
- LVEF < 35%
- Willing to sign informed consent
- On standard stable heart failure medical regimen (beta blockers and ACE-I or ARBs) for at least 1 month before randomization, if tolerated
- Patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information
- Patient has the ability to comply with study procedures and protocol, including required study visits
Exclusion Criteria:
- candidate for CRT or has a previously implanted CRT device
- previously implanted implantable pulse generators (IPG) or implantable cardioverter defibrillator (ICD) with at least 10 % pacing in the right ventricle
- patient has life expectancy <6 months
- patient is pregnant
- significant aortic stenosis
- uncontrolled hypertension
- mitral valve stenosis
- severe mitral valve calcification
- ruptured chordae tendinae or papillary muscle
- mitral valve leaflet disorders (i.e. endocarditis, lupus, tumors, rheumatic heart disease)
- chronic mitral leaflet degeneration (ie. Marfans)
- previous valve replacement or surgery
- IV inotropes or IV vasodilators
- candidate for mitral valve repair or replacement surgery within the next 6 months
- patient has in-hospital acute coronary syndrome (ACS) (NSTEMI/STEMI) prior to randomization
- patient has planned or elective percutaneous coronary intervention (PCI) or other non-cardiac surgery prior to randomization
- patient is currently enrolled in an investigational drug or device study
- patient is clinically unstable per PI assessment
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: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: CRT ON
After implant, patients will be randomized to CRT pacing ON vs OFF in crossover fashion with 3 months in each period
|
The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR.
The treatment being studied is CRT pacing therapy with standard of care LV lead placement.
Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months.
This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods.
|
|
Annen: CRT- OFF
After implant, patients will be randomized to CRT pacing OFF vs ON in crossover fashion with 3 months in each period
|
The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR.
The treatment being studied is CRT pacing therapy with standard of care LV lead placement.
Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months.
This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Chronic(8 months post-implant) benefit of MR reduction
Tidsramme: Chronic
|
To show that CRT pacing in patients with severe functional MR who are not currently indicated for CRT will demonstrate chronic(8 months post-implant) benefit of MR reduction (via echo measured MR/LA area and ERO per American Society of Echo guidelines)
|
Chronic
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To compare MR Severity (ERO and MR/LA area), heart volume and dimensions via echo and clinical symptoms between two pacing modalities
Tidsramme: Chronic
|
Secondary objectives will compare MR severity (ERO and MR/LA area), heart volume and dimensions via echo (LA and LV), LVEF via echo (Simpson's method and clinical sypmtoms (NYHA class, QOL, 6MHW distance) between the two pacing modalities (CRT ON and OFF)
|
Chronic
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Patrick Hranitzky, MD, Duke University
- Hovedetterforsker: Helbert Acosta, MD, Trinity Medical Center
- Hovedetterforsker: Adam A Berman, MD, Augusta University
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
1. januar 2011
Primær fullføring (Forventet)
1. januar 2012
Studiet fullført (Forventet)
1. januar 2013
Datoer for studieregistrering
Først innsendt
10. november 2010
Først innsendt som oppfylte QC-kriteriene
16. november 2010
Først lagt ut (Anslag)
17. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. desember 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. desember 2010
Sist bekreftet
1. november 2009
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MiRBi- Acosta
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