More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
NCT ID: NCT01510652
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1078 participants
INTERVENTIONAL
2011-11-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Quad Group
Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Quad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet
BiP Group
Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
BiP Group
Implantation of standard Left Ventricular (LV) lead
Interventions
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BiP Group
Implantation of standard Left Ventricular (LV) lead
Quad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet
Eligibility Criteria
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Inclusion Criteria
* Patients age is 18 years or greater
* Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
* Patients must be willing and able to comply with all study requirements
Exclusion Criteria
* Patients who are or may potentially be pregnant.
* Patient has suffered any of the following in the 4 weeks prior to enrolment:
* Myocardial Infarction (MI)
* Coronary Artery Bypass Graft (CABG)
* Unstable Angina Pectoris
* Patient has primary valvular disease which has not been corrected
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Giuseppe Boriani, Pro.
Role: PRINCIPAL_INVESTIGATOR
Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
Locations
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Ziekenhuis Oost-Limburg
Genk, , Belgium
Hopital La Citadelle
Liège, , Belgium
Foothills Medical Center
Calgary, , Canada
Royal Alexandra Hospital
Edmonton, , Canada
QE II Health Sciences
Halifax, , Canada
Institut de Cardiologie du Quebec - Hopital Laval
Québec, , Canada
HSC Heastern Health
St. Johns, , Canada
Paijat-Hame Central Hospital
Lahti, , Finland
Tampere University Hospital
Tampere, , Finland
CHU La Cavale Blanche
Brest, , France
CHU Gabriel Montpied
Clermont-Ferrand, , France
CHRU Hopital Albert Michallon
Grenoble, , France
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, , France
Hopital de la Timone
Marseille, , France
Hopital du Nord - CH Bourrely St. Antoine
Marseille, , France
CHU Hopital G&R Laennec
Nantes, , France
Nouvelles Cliniques Nantaises
Nantes, , France
CHRU Hopital de Pontchaillou
Rennes, , France
CHRU Hopital Charles Nicolle
Rouen, , France
CHU St. Etienne
Saint-Priest-en-Jarez, , France
Clinique du Tonkin
Villeurbanne, , France
Charite Campus Virchow Klinikum
Berlin, , Germany
Unfallkrankenhaus Berlin-Marzahn
Berlin, , Germany
Stadtische Kliniken Bielefeld
Bielefeld, , Germany
Klinikum Coburg
Coburg, , Germany
Elisabeth-Krankenhaus
Essen, , Germany
Universitatsklinikum Greifswald
Greifswald, , Germany
Universitatskliniken des Saarlandes
Homburg, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Stadtisches Klinikum Ludwigshafen
Ludwigshafen, , Germany
Klinikum Ludenscheid
Lüdenscheid, , Germany
Krankenhaus der Barmherzigen
Trier, , Germany
All India Institute of Medical Sciences
New Delhi, , India
Escorts Heart Institute and Research Center
New Delhi, , India
Barzilai Medical Center
Ashkelon, , Israel
Soroka University Hospital
Beersheba, , Israel
Kaplan Medical Center
Rehovot, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Policlinico S. Orsola & Malpighi
Bologna, , Italy
Azienda Ospedaliera S.Anna e S.Sebastiano
Caserta, , Italy
Azienda Ospedaliera Mater Domini
Catanzaro, , Italy
Ospedale Vito Fazzi
Lecce, , Italy
Ospedale Maggiore della Carità
Novara, , Italy
Policlinico Casilino
Rome, , Italy
Ospedale SS. Annunziata
Taranto, , Italy
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Torino, , Italy
Ospedale Civile Maggiore Verona Borgo Trento
Verona, , Italy
Amphia Hospital
Breda, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Haga Ziekenhuis
The Hague, , Netherlands
MC Haaglanden
The Hague, , Netherlands
Slaskie Centrum Chorob Serca
Zabrze, , Poland
Hospital de Basurto
Bilbao, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitari La Fe
Valencia, , Spain
Basel University Hospital
Basel, , Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, , Switzerland
Fondazione Cardiocentro Ticino
Lugano, , Switzerland
Universitaets Spital Zuerich
Zurich, , Switzerland
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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References
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Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11.
Other Identifiers
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CR-11-006-HF-ID
Identifier Type: -
Identifier Source: org_study_id
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