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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01510652
First received: November 30, 2011
Last updated: October 22, 2015
Last verified: October 2015

November 30, 2011
October 22, 2015
November 2011
May 2014   (final data collection date for primary outcome measure)
Lead Performance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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.

Lead Performance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
measures the intra-procedural and post-procedural performance of SJM LV quadripolar Quartet lead compared to any other standard bipolar LV lead
Complete list of historical versions of study NCT01510652 on ClinicalTrials.gov Archive Site
  • Percentage of Cardiac Resynchronization Therapy Responders [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
  • Implant Duration [ Time Frame: Total duration of the implant procedure reported at the end of the procedure ] [ Designated as safety issue: No ]
    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 CRT responders [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of CRT responders measured by a decrease of at least 10% of LVESV
  • Implant Duration [ Time Frame: Until completion of implantation procedure ] [ Designated as safety issue: No ]
    The total implant procedure duration time will be compared between the control and the treatment group.
Not Provided
Not Provided
 
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Postoperative Cardiac Complication
  • Heart Failure,
  • Left Ventricular Cardiac Dysfunction
  • Inappropriate Phrenic Nerve Stimulation
  • Perioperative/Postoperative Complications
  • Procedure: BiP Group
    Implantation of standard Left Ventricular (LV) lead
  • Device: Quad Group
    Implantation of quadripolar Left ventricular (LV) lead Quartet
  • Active Comparator: Quad Group
    Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
    Intervention: Device: Quad Group
  • 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)
    Intervention: Procedure: BiP Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1078
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Finland,   France,   Germany,   India,   Israel,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
Ireland
 
NCT01510652
CR-11-006-HF-ID
No
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Giuseppe Boriani, Pro. Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
St. Jude Medical
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP