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Trial record 3 of 11 for:    QUADRA

Quadripolar Leads for the Management of Heart Failure Patients in the Middle East (QUADRA-ME)

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ClinicalTrials.gov Identifier: NCT02195843
Recruitment Status : Unknown
Verified July 2014 by Abdulmohsen Al Musa'ad, MD, King Abdullah International Medical Research Center.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Abdulmohsen Al Musa'ad, MD, King Abdullah International Medical Research Center

Tracking Information
First Submitted Date  ICMJE July 15, 2014
First Posted Date  ICMJE July 21, 2014
Last Update Posted Date July 21, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
Left Ventricular End Systolic Volume (LVESV) [ Time Frame: 6 months post baseline ]
Positive Clinical response defined as % change of Left Ventricular End Systolic Volume (LVESV) at 6 months follow up, compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quadripolar Leads for the Management of Heart Failure Patients in the Middle East
Official Title  ICMJE Quadripolar Leads for the Management of Heart Failure Patients in the Middle East
Brief Summary

Heart failure is the most rapidly growing cardiovascular condition in developed countries. Despite advances in medical therapy, patients with heart failure are at high risk for death and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an effective treatment for heart failure.

Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV lead cannot be implanted in patients undergoing a trans-venous system implantation. In this case, the patients may undergo multiple procedures before a lead is successfully implanted. These implant failures are not due to patient selection but rather to patients heart anatomy leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic stimulation) and poor electrical measurements.

The phrenic nerve is not part of the heart but runs near to this area on the way to a large muscle, called diaphragm, which separates the lung space from the space containing stomach, liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to this nerve, it can cause a small part of it to contract giving you an uncomfortable hiccupping sensation.

In many patients, phrenic nerve stimulation is not identified until after the implant procedure when movement and postural changes bring the LV lead into closer contact with the phrenic nerve.

The investigation is performed to demonstrate the equality of performance of two different modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical) optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Other: Electrical optimization by RVLV Conduction Time with VectSelect

    VectSelect Quartet multivector testing is a programmer-based feature that provides centralized vector testing and programming with the flexibility to select the appropriate pacing vector to meet individual patient needs.

    The Right ventricle - Left Ventricle (RV-LV) conduction time measurement will automatically identify the RV-LV conduction time for each LV electrode .

    Other Name: VectSelect Quartet multivector testing
  • Other: Anatomical optimization of device and leads
    Patients will be implanted with left ventricular leads which will be positioned most basal, most apical or midway in the left ventricle. This follows the physician's routine clinical practice and judgement.
  • Device: Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)
    All participants will be implanted with a St Jude Medical (SJM) Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system. Patients who fulfill the criteria for CRT D implant, will be invited to participate in this clinical investigation. Patients implanted with chronic leads requiring device upgrade to CRT-D can also be enrolled in the study, provided they are receiving a CRT-D device for the first time.
Study Arms  ICMJE
  • Active Comparator: Emperical
    Anatomical optimization of device and leads
    Interventions:
    • Other: Anatomical optimization of device and leads
    • Device: Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)
  • Active Comparator: Electrical
    Electrical optimization by RVLV Conduction Time with VectSelect
    Interventions:
    • Other: Electrical optimization by RVLV Conduction Time with VectSelect
    • Device: Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 18, 2014)
389
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age
  • Patient met standard CRT-D device indications (Left Ventricular Ejection Fraction (LVEF) ≤ 35%, QRS ≥ 120 ms, New York Heart Association (NYHA) Class II, III or ambulatory Class IV Heart Failure (HF) symptoms with optimal recommended medical therapy) and will be implanted with an St Jude Medical CRT-D
  • Patient is willing to provide written informed consent.

Exclusion Criteria:

  • Patient with non left bundle branch block (RBBB, intraventricular delay (IVCD) Block)
  • Patient has an epicardial ventricular lead system.
  • Patient has limited intrinsic atrial activity (≤ 40 bpm).
  • Patient has persistent or permanent Atrial Fibrillation.
  • Patient's life expectancy is less than 1 year
  • Patient is pregnant.
  • Patient is dependent on IV inotropic agents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02195843
Other Study ID Numbers  ICMJE SA-2014-07-10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abdulmohsen Al Musa'ad, MD, King Abdullah International Medical Research Center
Study Sponsor  ICMJE King Abdullah International Medical Research Center
Collaborators  ICMJE Abbott Medical Devices
Investigators  ICMJE Not Provided
PRS Account King Abdullah International Medical Research Center
Verification Date July 2014

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