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

This study is currently recruiting participants.
Verified August 2012 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01510652
First received: November 30, 2011
Last updated: August 20, 2012
Last verified: August 2012

November 30, 2011
August 20, 2012
November 2011
May 2014   (final data collection date for primary outcome measure)
Lead performance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
measures the intra-procedural and post-procedural performance of St. Jude Medical Left Ventricular (SJM LV) quadripolar Quartet lead compared to any other standard bipolar Left Ventricular (LV) lead
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: 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: 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.
  • 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: Standard Left Ventricular (LV) lead
    Implantation of standard Left Ventricular (LV) lead
  • Device: Quartet Left Ventricular (LV) lead
    Implantation of quadripolar Left ventricular (LV) lead Quartet
  • Active Comparator: Study Group
    Patients in the Study group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
    Intervention: Device: Quartet Left Ventricular (LV) lead
  • Active Comparator: Control Group
    Patients in the Control 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: Standard Left Ventricular (LV) lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1062
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
No
Contact: Giuseppe Boriani, Prof. giuseppe.boriani@unibo.it
Belgium,   Germany,   Ireland,   Italy,   Netherlands
 
NCT01510652
CR-11-006-HF-ID
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Giuseppe Boriani, Pro. Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
St. Jude Medical
August 2012

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