More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges (MORE-CRT)

January 31, 2019 updated by: Abbott Medical Devices

More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1078

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Liège, Belgium
        • Hôpital La Citadelle
  • Canada
      • Calgary, Canada
        • Foothills Medical Center
      • Edmonton, Canada
        • Royal Alexandra Hospital
      • Halifax, Canada
        • QE II Health Sciences
      • Quebec, Canada
        • Institut de Cardiologie du Quebec - Hopital Laval
      • St. Johns, Canada
        • HSC Heastern Health
  • Finland
      • Lahti, Finland
        • Päijät-Häme Central hospital
      • Tampere, Finland
        • Tampere University hospital
  • France
      • Brest, France
        • CHU La Cavale Blanche
      • Clermont-Ferrand, France
        • CHU Gabriel Montpied
      • Grenoble, France
        • CHRU Hopital Albert Michallon
      • Lyon, France
        • Hopital Cardiovasculaire et Pneumologique Louis Pradel
      • Marseille, France
        • Hopital de la Timone
      • Marseille, France
        • Hopital du Nord - CH Bourrely St. Antoine
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Nantes, France
        • CHU Hopital G&R Laennec
      • Rennes, France
        • CHRU Hopital de Pontchaillou
      • Rouen, France
        • CHRU Hopital Charles Nicolle
      • Saint Priest en Jarez, France
        • CHU St. Etienne
      • Villeurbanne, France
        • Clinique du Tonkin
  • Germany
      • Berlin, Germany
        • Charite Campus Virchow Klinikum
      • Berlin, Germany
        • Unfallkrankenhaus Berlin-Marzahn
      • Bielefeld, Germany
        • Städtische Kliniken Bielefeld
      • Coburg, Germany
        • Klinikum Coburg
      • Essen, Germany
        • Elisabeth-Krankenhaus
      • Greifswald, Germany
        • Universitätsklinikum Greifswald
      • Homburg, Germany
        • Universitätskliniken des Saarlandes
      • Leipzig, Germany
        • Universitätsklinikum Leipzig
      • Ludenscheid, Germany
        • Klinikum Lüdenscheid
      • Ludwigshafen, Germany
        • Städtisches Klinikum Ludwigshafen
      • Trier, Germany
        • Krankenhaus der Barmherzigen
  • India
      • New Delhi, India
        • All India Institute of Medical Sciences
      • New Delhi, India
        • Escorts Heart Institute and Research Center
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Beer Sheba, Israel
        • Soroka University Hospital
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Hashomer, Israel
        • Sheba Medical Center
  • Italy
      • Bologna, Italy
        • Policlinico S. Orsola & Malpighi
      • Caserta, Italy
        • Azienda Ospedaliera S.Anna e S.Sebastiano
      • Catanzaro, Italy
        • Azienda Ospedaliera Mater Domini
      • Lecce, Italy
        • Ospedale Vito Fazzi
      • Novara, Italy
        • Ospedale Maggiore della Carità
      • Rome, Italy
        • Policlinico Casilino
      • Taranto, Italy
        • Ospedale Ss. Annunziata
      • Torino, Italy
        • Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
      • Verona, Italy
        • Ospedale Civile Maggiore Verona Borgo Trento
  • Netherlands
      • Breda, Netherlands
        • Amphia Hospital
      • Den Haag, Netherlands
        • Haga ziekenhuis
      • Den Haag, Netherlands
        • MC Haaglanden
      • Enschede, Netherlands
        • Medisch Spectrum Twente
  • Poland
      • Zabrze, Poland
        • Slaskie Centrum Chorob Serca
  • Spain
      • Bilbao, Spain
        • Hospital de Basurto
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Valencia, Spain
        • Hospital Universitari La Fe
  • Switzerland
      • Basel, Switzerland
        • Basel University Hospital
      • Geneva, Switzerland
        • Hopital Cantonal Universitaire de Geneva
      • Lugano, Switzerland
        • Fondazione Cardiocentro Ticino
      • Zurich, Switzerland
        • Universitaets Spital Zuerich
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • London, United Kingdom
        • St. Thomas Hospital
      • Middlesbrough, United Kingdom
        • James Cook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quad Group
Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Device: Quad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet
Active Comparator: 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)
Procedure: BiP Group
Implantation of standard Left Ventricular (LV) lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead Performance
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Cardiac Resynchronization Therapy Responders
Time Frame: 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)
Baseline and 6 months
Implant Duration
Time Frame: 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.
Total duration of the implant procedure reported at the end of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Giuseppe Boriani, Pro., Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-11-006-HF-ID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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