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

This study has been completed.

Sponsor:

Information provided by:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT00158951

First received: September 8, 2005

Last updated: June 22, 2007

Last verified: June 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2005
Last Updated Date	June 22, 2007
Start Date ^ICMJE	March 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: October 23, 2006)	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
Original Primary Outcome Measures ^ICMJE (submitted: September 8, 2005)	·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
Change History	Complete list of historical versions of study NCT00158951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 23, 2006)	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
Original Secondary Outcome Measures ^ICMJE (submitted: September 8, 2005)	·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
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF
Official Title ^ICMJE	Device Evaluation of CONTAK(R) RENEWAL 2/4/4HE and EASYTRAK(R) 2: Assessment of Safety and Effectiveness in Heart Failure (DECREASE-HF)
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Congestive Heart Failure
Intervention ^ICMJE	Device: CONTAK RENEWAL 2/4/4HE CRT-D Device: EASYTRAK 2 Lead
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	360
Completion Date	October 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00158951
Other Study ID Numbers ^ICMJE	Clinicals0005
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Boston Scientific Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Boston Scientific Corporation
Verification Date	June 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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