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

July 18, 2014 updated by: Abdulmohsen Al Musa'ad, MD, King Abdullah International Medical Research Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

389

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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.
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 Names:
  • VectSelect Quartet multivector testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah International Medical Research Center

Collaborators

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA-2014-07-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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