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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1078

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Carita
      • 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 Ramon 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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