Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF - Full Text View

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Device: CONTAK RENEWAL 2/4/4HE CRT-D Device: EASYTRAK 2 Lead	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Device Evaluation of CONTAK(R) RENEWAL 2/4/4HE and EASYTRAK(R) 2: Assessment of Safety and Effectiveness in Heart Failure (DECREASE-HF)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Therapy Efficacy: Change in cardiac function at six-months
Therapy Safety: CRT does not increase HF related adverse events at six-months
Device Efficacy; Therapy does not affect ability to detect VF, Stable chronic LV thresholds, R-wave amplitudes and impedances
Device Safety: System complication free rate at six-months, Lead related complication free rate at six-months

Secondary Outcome Measures:

Therapy Efficacy: Change in cardiac function and reduced HF symptoms
Therapy Safety: Continuous appropriate pacing
Device Efficacy: Stable chronic LV thresholds, R-wave amplitudes and impedances from those not selected in final programming at six-months

Estimated Enrollment:	360
Study Start Date:	March 2003
Estimated Study Completion Date:	October 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158951

Locations

United States, Minnesota
Multiple Locations in the US
St. Paul, Minnesota, United States

Sponsors and Collaborators

Boston Scientific Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00158951 History of Changes
Other Study ID Numbers:	Clinicals0005
Study First Received:	September 8, 2005
Last Updated:	June 22, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Left Ventricular Lead
Cardiac Resynchronization Therapy
Congestive Heart Failure

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013