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

Primary Purpose

Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BiP Group
Quad Group
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cardiac Complication focused on measuring Cardiac Resynchronization therapy,, Heart Failure,, Left Ventricular Lead,, Quadripolar Left ventricular Lead,, Phrenic Nerve Stimulation,, Intra and post operative related complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg
  • Hopital La Citadelle
  • Foothills Medical Center
  • Royal Alexandra Hospital
  • QE II Health Sciences
  • Institut de Cardiologie du Quebec - Hopital Laval
  • HSC Heastern Health
  • Paijat-Hame Central Hospital
  • Tampere University Hospital
  • CHU La Cavale Blanche
  • CHU Gabriel Montpied
  • CHRU Hopital Albert Michallon
  • Hopital Cardiovasculaire et Pneumologique Louis Pradel
  • Hopital de la Timone
  • Hopital du Nord - CH Bourrely St. Antoine
  • CHU Hopital G&R Laennec
  • Nouvelles Cliniques Nantaises
  • CHRU Hopital de Pontchaillou
  • CHRU Hopital Charles Nicolle
  • CHU St. Etienne
  • Clinique du Tonkin
  • Charite Campus Virchow Klinikum
  • Unfallkrankenhaus Berlin-Marzahn
  • Stadtische Kliniken Bielefeld
  • Klinikum Coburg
  • Elisabeth-Krankenhaus
  • Universitatsklinikum Greifswald
  • Universitatskliniken des Saarlandes
  • Universitatsklinikum Leipzig
  • Klinikum Ludenscheid
  • Stadtisches Klinikum Ludwigshafen
  • Krankenhaus der Barmherzigen
  • All India Institute of Medical Sciences
  • Escorts Heart Institute and Research Center
  • Barzilai Medical Center
  • Soroka University Hospital
  • Kaplan Medical Center
  • Sheba Medical Center
  • Policlinico S. Orsola & Malpighi
  • Azienda Ospedaliera S.Anna e S.Sebastiano
  • Azienda Ospedaliera Mater Domini
  • Ospedale Vito Fazzi
  • Ospedale Maggiore della Carità
  • Policlinico Casilino
  • Ospedale SS. Annunziata
  • Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
  • Ospedale Civile Maggiore Verona Borgo Trento
  • Amphia Hospital
  • Haga Ziekenhuis
  • MC Haaglanden
  • Medisch Spectrum Twente
  • Slaskie Centrum Chorob Serca
  • Hospital de Basurto
  • Hospital Ramon y Cajal
  • Hospital Universitari La Fe
  • Basel University Hospital
  • Hopital Cantonal Universitaire de Geneva
  • Fondazione Cardiocentro Ticino
  • Universitaets Spital Zuerich
  • Queen Elizabeth Hospital
  • Royal Bournemouth Hospital
  • University Hospital of Wales
  • St. Thomas Hospital
  • James Cook University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quad Group

BiP Group

Arm Description

Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Cardiac Resynchronization Therapy Responders
Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
Implant Duration
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.

Full Information

First Posted
November 30, 2011
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01510652
Brief Title
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
Acronym
MORE-CRT
Official Title
More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation, Perioperative/Postoperative Complications
Keywords
Cardiac Resynchronization therapy,, Heart Failure,, Left Ventricular Lead,, Quadripolar Left ventricular Lead,, Phrenic Nerve Stimulation,, Intra and post operative related complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1078 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quad Group
Arm Type
Active Comparator
Arm Description
Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Arm Title
BiP Group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
BiP Group
Intervention Description
Implantation of standard Left Ventricular (LV) lead
Intervention Type
Device
Intervention Name(s)
Quad Group
Intervention Description
Implantation of quadripolar Left ventricular (LV) lead Quartet
Primary Outcome Measure Information:
Title
Lead Performance
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of Cardiac Resynchronization Therapy Responders
Description
Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
Time Frame
Baseline and 6 months
Title
Implant Duration
Description
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.
Time Frame
Total duration of the implant procedure reported at the end of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Boriani, Pro.
Organizational Affiliation
Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
Hopital La Citadelle
City
Liège
Country
Belgium
Facility Name
Foothills Medical Center
City
Calgary
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
Country
Canada
Facility Name
QE II Health Sciences
City
Halifax
Country
Canada
Facility Name
Institut de Cardiologie du Quebec - Hopital Laval
City
Quebec
Country
Canada
Facility Name
HSC Heastern Health
City
St. Johns
Country
Canada
Facility Name
Paijat-Hame Central Hospital
City
Lahti
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
CHU La Cavale Blanche
City
Brest
Country
France
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
Country
France
Facility Name
CHRU Hopital Albert Michallon
City
Grenoble
Country
France
Facility Name
Hopital Cardiovasculaire et Pneumologique Louis Pradel
City
Lyon
Country
France
Facility Name
Hopital de la Timone
City
Marseille
Country
France
Facility Name
Hopital du Nord - CH Bourrely St. Antoine
City
Marseille
Country
France
Facility Name
CHU Hopital G&R Laennec
City
Nantes
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
Country
France
Facility Name
CHRU Hopital de Pontchaillou
City
Rennes
Country
France
Facility Name
CHRU Hopital Charles Nicolle
City
Rouen
Country
France
Facility Name
CHU St. Etienne
City
Saint Priest en Jarez
Country
France
Facility Name
Clinique du Tonkin
City
Villeurbanne
Country
France
Facility Name
Charite Campus Virchow Klinikum
City
Berlin
Country
Germany
Facility Name
Unfallkrankenhaus Berlin-Marzahn
City
Berlin
Country
Germany
Facility Name
Stadtische Kliniken Bielefeld
City
Bielefeld
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
Country
Germany
Facility Name
Elisabeth-Krankenhaus
City
Essen
Country
Germany
Facility Name
Universitatsklinikum Greifswald
City
Greifswald
Country
Germany
Facility Name
Universitatskliniken des Saarlandes
City
Homburg
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum Ludenscheid
City
Ludenscheid
Country
Germany
Facility Name
Stadtisches Klinikum Ludwigshafen
City
Ludwigshafen
Country
Germany
Facility Name
Krankenhaus der Barmherzigen
City
Trier
Country
Germany
Facility Name
All India Institute of Medical Sciences
City
New Delhi
Country
India
Facility Name
Escorts Heart Institute and Research Center
City
New Delhi
Country
India
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Soroka University Hospital
City
Beer Sheba
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Name
Policlinico S. Orsola & Malpighi
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliera S.Anna e S.Sebastiano
City
Caserta
Country
Italy
Facility Name
Azienda Ospedaliera Mater Domini
City
Catanzaro
Country
Italy
Facility Name
Ospedale Vito Fazzi
City
Lecce
Country
Italy
Facility Name
Ospedale Maggiore della Carità
City
Novara
Country
Italy
Facility Name
Policlinico Casilino
City
Rome
Country
Italy
Facility Name
Ospedale SS. Annunziata
City
Taranto
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
City
Torino
Country
Italy
Facility Name
Ospedale Civile Maggiore Verona Borgo Trento
City
Verona
Country
Italy
Facility Name
Amphia Hospital
City
Breda
Country
Netherlands
Facility Name
Haga Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
MC Haaglanden
City
Den Haag
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Slaskie Centrum Chorob Serca
City
Zabrze
Country
Poland
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitari La Fe
City
Valencia
Country
Spain
Facility Name
Basel University Hospital
City
Basel
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneva
City
Geneva
Country
Switzerland
Facility Name
Fondazione Cardiocentro Ticino
City
Lugano
Country
Switzerland
Facility Name
Universitaets Spital Zuerich
City
Zurich
Country
Switzerland
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
St. Thomas Hospital
City
London
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29766873
Citation
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.
Results Reference
derived

Learn more about this trial

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

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