Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF

Boston Scientific

Status and phase

Completed

Phase 3

Phase 2

Conditions

Congestive Heart Failure

Treatments

Device: CONTAK RENEWAL 2/4/4HE CRT-D

Device: EASYTRAK 2 Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT00158951

Clinicals0005

Details and patient eligibility

About

The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the CONTAK® RENEWAL™ 2/4/4HE cardiac resynchronization therapy defibrillator (CRT-D) family and EASYTRAK® 2 lead in delivering LV-CRT or BiV-CRT with an LV Offset for patients with heart failure and an indication for an ICD.

Full description

This clinical investigation is a prospective, multi-center, randomized, double-blind study design enrolling 360 patients at 57 centers to demonstrate the safety and effectiveness of the therapy, the CONTAK RENEWAL 2/4/4HE devices and the EASYTRAK 2 lead.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet the general indications for a CRT-D device
Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy.
A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm, QRS duration ³ 150 ms, and PR interval £ 320 ms measured from any two leads, and a P-wave duration < 150 ms measured from lead V1
Creatinine £ 2.5 mg/dL obtained no more than 14 days prior to enrollment
Left ventricular ejection fraction £ 35% [measured by echo, multiple gated acquisition (MUGA) scan, cardiac catheterization, etc.] no more than 14 days prior to enrollment
Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
Have a life expectancy of more than 180 days, per physician discretion
Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

Right bundle branch block morphology (per World Health Organization Guidelines) on a 12-lead ECG obtained no more than 90 days prior to enrollment.
Have had previous cardiac resynchronization therapy, a previous coronary venous lead, or meet the general indications for antibradycardia pacing
Have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 180 days prior to enrollment
Have a hypersensitivity to a 0.7 mg dose of dexamethasone acetate
Have surgically uncorrected primary valvular heart disease
Currently requiring dialysis
Have chronic obstructive pulmonary disease (COPD), defined as FEV1/FVC < 60%
Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the 30 days prior to enrollment
Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
Have a mechanical tricuspid prosthesis
Enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study.