Quadripolar Leads for the Management of Heart Failure Patients in the Middle East

NCT ID: NCT02195843

Last Updated: 2014-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-08-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Emperical

Anatomical optimization of device and leads

Group Type: ACTIVE_COMPARATOR

Anatomical optimization of device and leads

Intervention Type: OTHER

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.

Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)

Intervention Type: DEVICE

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.

Electrical

Electrical optimization by RVLV Conduction Time with VectSelect

Group Type: ACTIVE_COMPARATOR

Electrical optimization by RVLV Conduction Time with VectSelect

Intervention Type: OTHER

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 .

Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)

Intervention Type: DEVICE

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.

Interventions

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 .

Intervention Type: 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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

VectSelect Quartet multivector testing

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

King Abdullah International Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Abdulmohsen Al Musa'ad, MD

Consultant Adult Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SA-2014-07-10

Identifier Type: -

Identifier Source: org_study_id