More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
MORE-CRT
1 other identifier
interventional
1,078
13 countries
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Typical duration for not_applicable
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
January 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
October 23, 2015
CompletedFebruary 15, 2019
January 1, 2019
2.5 years
November 30, 2011
August 14, 2015
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lead Performance
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.
6 months
Secondary Outcomes (2)
Percentage of Cardiac Resynchronization Therapy Responders
Baseline and 6 months
Implant Duration
Total duration of the implant procedure reported at the end of the procedure
Study Arms (2)
Quad Group
ACTIVE COMPARATORPatients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
BiP Group
ACTIVE COMPARATORPatients 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
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
Related Publications (1)
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.
PMID: 29766873DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Patients were followed for only 6 months, studies with longer follow-up would add to the body of evidence.
Results Point of Contact
- Title
- Prof. Giuseppe Boriani
- Organization
- Institute of Cardiology, Univ. of Bologna, Bologna, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Boriani, Pro.
Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
January 16, 2012
Study Start
November 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 15, 2019
Results First Posted
October 23, 2015
Record last verified: 2019-01