Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF
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ClinicalTrials.gov Identifier: NCT00158951 |
Recruitment Status
:
Completed
First Posted
: September 12, 2005
Last Update Posted
: June 25, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congestive Heart Failure | Device: CONTAK RENEWAL 2/4/4HE CRT-D Device: EASYTRAK 2 Lead | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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) |
Study Start Date : | March 2003 |
Study Completion Date : | October 2004 |

- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158951
United States, Minnesota | |
Multiple Locations in the US | |
St. Paul, Minnesota, United States |
ClinicalTrials.gov Identifier: | NCT00158951 History of Changes |
Other Study ID Numbers: |
Clinicals0005 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | June 25, 2007 |
Last Verified: | June 2007 |
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 |