- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02548455
Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study
Studieoversikt
Detaljert beskrivelse
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.
A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.
All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Alabama
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Huntsville, Alabama, Forente stater, 35801
- Heart Center Research
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Arizona
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Phoenix, Arizona, Forente stater, 85013
- Arizona Arrhythmia Research Center
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Arkansas
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Jonesboro, Arkansas, Forente stater, 72401
- Cardiology Associates of Northeast Arkansas
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California
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La Jolla, California, Forente stater, 92037
- Scripps Health
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Newport Beach, California, Forente stater, 92663
- Premier Cardiology, Inc.
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Stanford, California, Forente stater, 94305
- Stanford University Hospital
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Florida
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Ocala, Florida, Forente stater, 34471
- Munroe Regional Medical Center
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Tallahassee, Florida, Forente stater, 32308
- Tallahassee Research Institute
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital
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Gainesville, Georgia, Forente stater, 30501
- North Georgia Heart Foundation
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Iowa
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West Des Moines, Iowa, Forente stater, 50266
- Iowa Heart Center
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Kentucky
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Lexington, Kentucky, Forente stater, 40503
- Central Baptist Hospital
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Owensboro, Kentucky, Forente stater, 42304
- One Health Cardiology
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Michigan
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Lansing, Michigan, Forente stater, 48912
- Thoracic Cardiovascular Healthcare Foundation
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Missouri
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Columbia, Missouri, Forente stater, 65201
- Missouri Heart Center
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New Hampshire
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Manchester, New Hampshire, Forente stater, 03102
- Catholic Medical Center
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New Jersey
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Haddon Heights, New Jersey, Forente stater, 08035
- Cardiovascular Associates of Delaware Valley
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27103
- Forsyth Medical Center
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals of Cleveland
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74104
- Oklahoma Heart Institute at Utica
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Pennsylvania
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Lancaster, Pennsylvania, Forente stater, 17602
- Lancaster General Hospital
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Sayre, Pennsylvania, Forente stater, 18840
- Donald Guthrie Foundation for Education & Research
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Greenville Health System
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37403
- Erlanger Medical Center
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Germantown, Tennessee, Forente stater, 38138
- The Stern Cardiovascular Foundation
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Texas
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Plano, Texas, Forente stater, 75093
- The Heart Hospital Baylor Plano
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Washington
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Seattle, Washington, Forente stater, 98122
- Swedish Medical Center - Heart & Vascular
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Wisconsin
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Madison, Wisconsin, Forente stater, 53715
- St. Mary's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:
" to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
- Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
- Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion Criteria:
- Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
- Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
- Are pregnant or planning pregnancy in the next 6 months
- Have a life expectancy of less than 24 months due to any condition
Studieplan
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: Treatment
Subjects implanted with the Quartet 1457Q LV lead
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients Free From LV Lead-related Complications Through 3 Months
Tidsramme: 3 months
|
A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead.
A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
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3 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: David Delurgio, MD, Emory University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Hjertefeil
- Fysiologiske effekter av legemidler
- Prevensjonsmidler, hormonelle
- Prevensjonsmidler
- Reproduktive kontrollmidler
- Prevensjonsmidler, orale, kombinert
- Prevensjonsmidler, Oral
- Prevensjonsmidler, kvinner
- Etinyløstradiol, levonorgestrel medikamentkombinasjon
Andre studie-ID-numre
- CRD 616
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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Kliniske studier på Quartet 1457Q LV Lead
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Biotronik, Inc.FullførtKongestiv hjertesviktForente stater