POsition of Leads in Advanced heaRt Failure: the POLAR Study (POLAR)
23. januar 2012 oppdatert av: Sergio Thal, M.D.
POsition of Leads in Advanced heaRt Failure: the POLAR Study - A 6 Month, Observational, Mult-centered, Blinded, Randomized Study to Determine if Lead Positioning in the Lateral Wall of LV in Patients Meeting Criteria for CRT Plays a Role in Determining Myocardial Function and Affect the Severity of Mitral Regurgitation
The primary objective is to determine if lead positioning in the lateral wall of the left ventricle in patients meeting criteria for cardiac resynchronization therapy plays a role in determining myocardial function and affects the severity of mitral regurgitation.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
This is a 6 month, multi-centered, blinded, randomized study.
Approximately 60 patients will join this study.
Two groups, based on lead position, will be studied with thirty (30) patients randomized into each group.
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arizona
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Tucson, Arizona, Forente stater, 85723
- Rekruttering
- Southern Arizona VA Health Care System
-
Ta kontakt med:
- Sergio Thal, M.D.
- Telefonnummer: 4624 520-792-1450
- E-post: sergio.thal@va.gov
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Ta kontakt med:
- Elizabeth Juneman, M.D.
- Telefonnummer: 4624 520-792-1450
- E-post: elizabeth.juneman@va.gov
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Hovedetterforsker:
- Sergio Thal, M.D.
-
Underetterforsker:
- Elizabeth Juneman, M.D.
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Underetterforsker:
- Hoang Thai, M.D.
-
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Kentucky
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Lexington, Kentucky, Forente stater, 40502
- Rekruttering
- Lexington VA Medical Center
-
Ta kontakt med:
- Samy Elayi, M.D.
- Telefonnummer: 859-233-4511
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Hovedetterforsker:
- Samy Elayi, M.D.
-
-
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 meets the general indications for an implantable cardioverter defibrillator (ICD) with LV systolic function ≤ 35% as defined by echocardiography.
- Subject has moderate or severe heart failure, defined as NYHA Class III-IV for at least 90 days prior to enrollment.
- Subject has optimal pharmacological heart failure therapy for at least 30 days prior to enrollment.
- Subject has a 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm and PR interval < 320 ms measured from any two leads.
- 12 lead ECG with left bundle brunch block morphology and a QRS duration of at least 120 msec.
- Subject has creatinine < 2.5 mg/dL obtained no more than 30 days prior to enrollment.
- Subject has left ventricular ejection fraction < 35% by echocardiogram no more than 1 year prior to enrollment.
- Subject is willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation.
- Subject has a life expectancy of more than 180 days, per physician discretion.
- Subject is age 18 or above, or of legal age to give informed consent specific to state and national law.
Exclusion Criteria:
- Subject has right bundle branch block morphology on a 12-lead ECG obtained no more than 90 days prior to enrollment.
- Subject had previous cardiac resynchronization therapy, a previous coronary venous lead, or meets the general indications for anti-bradycardia pacing defined as ventricular pacing > 40% by pacemaker interrogation.
- Subject has a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking.
- Subject has an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 30 days prior to enrollment.
- Subject currently requires dialysis.
- Subject has severe chronic obstructive pulmonary disease (COPD), defined as FEV1/FVC < 60%, or as defined by a physician.
- Subject has had a myocardial infarction within 30 days prior to enrollment or coronary artery disease (CAD) in which surgical or percutaneous correction was performed within 30 days prior to enrollment.
- Subject has hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
- Subject is on IV inotropic agents.
- Subject has any mitral valve prosthesis, or a mechanical aortic or tricuspid prosthesis
- Subject is enrolled in any concurrent study, without Medtronic written approval, which may confound the results of this study.
- Subject is pregnant or planning to get pregnant.
- Subject requires oxygen for medical reasons other than CHF.
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: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Postero-lateral
Left ventricular lateral wall lead position
|
A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization.
|
|
Aktiv komparator: Antero-lateral
Left ventricular lateral wall lead position
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A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change (reduction) in left ventricular end systolic volume (LVESV)
Tidsramme: 3 and 6 months
|
3 and 6 months
|
|
Change in 6 minute walk tests
Tidsramme: 6 weeks, 3 and 6 months
|
6 weeks, 3 and 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Myocardial performance as measured by myocardial performance index (MPI)
Tidsramme: 6 months
|
6 months
|
|
|
Papillary muscle velocity as determined by tissue doppler
Tidsramme: 6 months
|
6 months
|
|
|
Progression of mitral regurgitation
Tidsramme: 6 months
|
as measured by regurgitant volume, mitral regurgitation fraction and effective regurgitant orifice area
|
6 months
|
|
Minnesota living heart failure survey
Tidsramme: 6 weeks, 3 and 6 months
|
6 weeks, 3 and 6 months
|
|
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Chronic heart failure hospitalizations
Tidsramme: Monitored during study participation ~ 6 months
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Monitored during study participation ~ 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Sergio Thal, M.D., Southern Arizona VA Health Care System
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. september 2010
Primær fullføring (Forventet)
1. mars 2013
Datoer for studieregistrering
Først innsendt
12. januar 2012
Først innsendt som oppfylte QC-kriteriene
23. januar 2012
Først lagt ut (Anslag)
24. januar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. januar 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. januar 2012
Sist bekreftet
1. januar 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PIIT1A
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