More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
- Conditions
- Heart FailurePostoperative Cardiac ComplicationInappropriate Phrenic Nerve StimulationLeft Ventricular Cardiac DysfunctionPerioperative/Postoperative Complications
- Interventions
- Device: Quad GroupProcedure: BiP Group
- Registration Number
- NCT01510652
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1078
- Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
- 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
-
Patients with a life expectancy <12 months.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quad Group Quad Group Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet BiP Group 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)
- Primary Outcome Measures
Name Time Method Lead Performance 6 months Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.
Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.
- Secondary Outcome Measures
Name Time Method Implant Duration Total duration of the implant procedure reported at the end of the procedure This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.
Percentage of Cardiac Resynchronization Therapy Responders Baseline and 6 months Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
Trial Locations
- Locations (64)
Policlinico Casilino
🇮🇹Rome, Italy
Azienda Ospedaliera S.Anna e S.Sebastiano
🇮🇹Caserta, Italy
Azienda Ospedaliera Mater Domini
🇮🇹Catanzaro, Italy
Ospedale SS. Annunziata
🇮🇹Taranto, Italy
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
🇮🇹Torino, Italy
Haga Ziekenhuis
🇳🇱Den Haag, Netherlands
Ospedale Vito Fazzi
🇮🇹Lecce, Italy
Ospedale Maggiore della Carità
🇮🇹Novara, Italy
Foothills Medical Center
🇨🇦Calgary, Canada
QE II Health Sciences
🇨🇦Halifax, Canada
Royal Alexandra Hospital
🇨🇦Edmonton, Canada
Institut de Cardiologie du Quebec - Hopital Laval
🇨🇦Quebec, Canada
HSC Heastern Health
🇨🇦St. Johns, Canada
CHRU Hopital Albert Michallon
🇫🇷Grenoble, France
CHU La Cavale Blanche
🇫🇷Brest, France
Hopital de la Timone
🇫🇷Marseille, France
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hopital Cardiovasculaire et Pneumologique Louis Pradel
🇫🇷Lyon, 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
Unfallkrankenhaus Berlin-Marzahn
🇩🇪Berlin, Germany
Clinique du Tonkin
🇫🇷Villeurbanne, France
CHU St. Etienne
🇫🇷Saint Priest en Jarez, France
Stadtische Kliniken Bielefeld
🇩🇪Bielefeld, Germany
Charite Campus Virchow Klinikum
🇩🇪Berlin, Germany
Klinikum Coburg
🇩🇪Coburg, Germany
Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Elisabeth-Krankenhaus
🇩🇪Essen, Germany
Universitatsklinikum Greifswald
🇩🇪Greifswald, Germany
Universitatskliniken des Saarlandes
🇩🇪Homburg, Germany
Klinikum Ludenscheid
🇩🇪Ludenscheid, Germany
Stadtisches Klinikum Ludwigshafen
🇩🇪Ludwigshafen, Germany
Krankenhaus der Barmherzigen
🇩🇪Trier, Germany
Soroka University Hospital
🇮🇱Beer Sheba, Israel
Policlinico S. Orsola & Malpighi
🇮🇹Bologna, Italy
Ospedale Civile Maggiore Verona Borgo Trento
🇮🇹Verona, Italy
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitari La Fe
🇪🇸Valencia, Spain
Basel University Hospital
🇨🇭Basel, 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
Hopital La Citadelle
🇧🇪Liège, Belgium
Tampere University Hospital
🇫🇮Tampere, Finland
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
Paijat-Hame Central Hospital
🇫🇮Lahti, Finland
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Escorts Heart Institute and Research Center
🇮🇳New Delhi, India
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Slaskie Centrum Chorob Serca
🇵🇱Zabrze, Poland
Amphia Hospital
🇳🇱Breda, Netherlands
MC Haaglanden
🇳🇱Den Haag, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Hopital Cantonal Universitaire de Geneva
🇨🇭Geneva, Switzerland
Fondazione Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Universitaets Spital Zuerich
🇨🇭Zurich, Switzerland