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
  Purpose

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.


Condition Intervention
Postoperative Cardiac Complication
Heart Failure,
Left Ventricular Cardiac Dysfunction
Inappropriate Phrenic Nerve Stimulation
Perioperative/Postoperative Complications
Procedure: Standard Left Ventricular (LV) lead
Device: Quartet Left Ventricular (LV) lead

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1062
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study Group
Patients in the Study group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
Device: Quartet Left Ventricular (LV) lead
Implantation of quadripolar Left ventricular (LV) lead Quartet
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)
Procedure: Standard Left Ventricular (LV) lead
Implantation of standard Left Ventricular (LV) lead

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510652

Contacts
Contact: Giuseppe Boriani, Prof. giuseppe.boriani@unibo.it

Locations
Belgium
Hopital La Citadelle Not yet recruiting
Liège, Belgium
Contact: Jean Borland, Dr.         
Principal Investigator: Jean Borland, Dr.         
Germany
Klinikum Ludenscheid Recruiting
Ludenscheid, Germany
Contact: Bernd Lemke, Prof.         
Principal Investigator: Bernd Lemke, Prof.         
Ireland
Beaumont Hospital Not yet recruiting
Dublin, Ireland
Contact: Ricky Sheahan, Dr.         
Principal Investigator: Ricky Sheahan, Dr.         
Italy
Policlinico S. Orsola & Malpighi Not yet recruiting
Bologna, Italy
Contact: Giuseppe Boriani, Prof.    +390516363598    giuseppe.boriani@unibo.it   
Principal Investigator: Giuseppe Boriani, Prof.         
Ospedale SS. Annunziata Not yet recruiting
Taranto, Italy
Contact: Vitantonio Russo, Prof.         
Principal Investigator: Vitantonio Russo, Prof.         
Netherlands
MC Haaglanden Recruiting
Den Haag, Netherlands
Contact: Alexander Wardeh, Dr.       a.wardeh@mchaaglanden.nl   
Principal Investigator: Alexander Wardeh, Dr.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Giuseppe Boriani, Pro. Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01510652     History of Changes
Other Study ID Numbers: CR-11-006-HF-ID
Study First Received: November 30, 2011
Last Updated: August 20, 2012
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Independent Ethics Committee

Keywords provided by St. Jude Medical:
Cardiac Resynchronization therapy,
Heart Failure,
Left Ventricular Lead,
Quadripolar Left ventricular Lead,
Phrenic Nerve Stimulation,
Intra and post operative related complications

Additional relevant MeSH terms:
Heart Failure
Postoperative Complications
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014