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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CONTAK RENEWAL 2/4/4HE CRT-D
EASYTRAK 2 Lead
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Left Ventricular Lead, Cardiac Resynchronization Therapy, Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Multiple Locations in the US

Outcomes

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

Full Information

First Posted
September 8, 2005
Last Updated
June 22, 2007
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00158951
Brief Title
Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF
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 Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Left Ventricular Lead, Cardiac Resynchronization Therapy, Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CONTAK RENEWAL 2/4/4HE CRT-D
Intervention Type
Device
Intervention Name(s)
EASYTRAK 2 Lead
Primary Outcome Measure Information:
Title
Therapy Efficacy: Change in cardiac function at six-months
Title
Therapy Safety: CRT does not increase HF related adverse events at six-months
Title
Device Efficacy; Therapy does not affect ability to detect VF, Stable chronic LV thresholds, R-wave amplitudes and impedances
Title
Device Safety: System complication free rate at six-months, Lead related complication free rate at six-months
Secondary Outcome Measure Information:
Title
Therapy Efficacy: Change in cardiac function and reduced HF symptoms
Title
Therapy Safety: Continuous appropriate pacing
Title
Device Efficacy: Stable chronic LV thresholds, R-wave amplitudes and impedances from those not selected in final programming at six-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Multiple Locations in the US
City
St. Paul
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

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

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