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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

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.


Condition or disease Intervention/treatment Phase
Heart Failure Other: Electrical optimization by RVLV Conduction Time with VectSelect Other: Anatomical optimization of device and leads Device: Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Quadripolar Leads for the Management of Heart Failure Patients in the Middle East
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Emperical
Anatomical optimization of device and leads
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.

Active Comparator: Electrical
Electrical optimization by RVLV Conduction Time with VectSelect
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

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Abdulmohsen Al Musa'ad, MD, Consultant Adult Cardiologist, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT02195843     History of Changes
Other Study ID Numbers: SA-2014-07-10
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: July 2014
Keywords provided by Abdulmohsen Al Musa'ad, MD, King Abdullah International Medical Research Center:
CRT-D
Heart Failure
Middle East
Quadripolar
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs