Clinical Trial: DECREASE-HF

This study is no longer recruiting patients.

Sponsored by: Guidant Corporation
Information provided by: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00158951

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 II
Phase III

MedlinePlus related topics:  Heart Failure

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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)

Further Study Details: 
Primary Outcomes: ·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 Outcomes: ·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
Expected Total Enrollment:  360

Study start: March 2003
Last follow-up: October 2004

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 above,  Genders Eligible for Study:  Both
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.

Location Information


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

More Information

Study ID Numbers:  Clinicals0005
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158951
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13

Resources

  • Lead (Centers for Disease Control and Prevention)
  • Lead (Lab Tests Online)



Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us