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

NCT02195843 | Unknown Phase 4

• 1 other identifier: SA-2014-07-10
• Study Type: interventional
• Target: 389
• Locations: 0 countries
• Sites: N/A

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

Keywords

CRT-D; Heart Failure; Middle East; Quadripolar

Outcome Measures

Primary Outcomes (1)

• Left Ventricular End Systolic Volume (LVESV)

  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

Study Arms (2)

Emperical

ACTIVE COMPARATOR

Anatomical optimization of device and leads

Other: Anatomical optimization of device and leads; Device: Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)

Electrical

ACTIVE COMPARATOR

Electrical optimization by RVLV Conduction Time with VectSelect

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)

Interventions

Electrical optimization by RVLV Conduction Time with VectSelect 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 .

Also known as: VectSelect Quartet multivector testing

Electrical

Anatomical optimization of device and leads 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.

Emperical

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead
• Abbott Medical Devices: collaborator

MeSH Terms

Conditions

Heart Failure

Interventions

Lead

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Adult Cardiologist

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 21, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 21, 2014

Record last verified: 2014-07