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

Congestive Heart Failure Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158951
• Other study ID #: Clinicals0005
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: June 22, 2007
• Start date: March 2003
• Est. completion date: October 2004

Study information

• Verified date: June 2007
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• CONTAK RENEWAL 2/4/4HE CRT-D

• EASYTRAK 2 Lead

Locations

Country	Name	City	State
United States	Multiple Locations in the US	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy Efficacy: Change in cardiac function at six-months
Primary	Therapy Safety: CRT does not increase HF related adverse events at six-months
Primary	Device Efficacy; Therapy does not affect ability to detect VF, Stable chronic LV thresholds, R-wave amplitudes and impedances
Primary	Device Safety: System complication free rate at six-months, Lead related complication free rate at six-months
Secondary	Therapy Efficacy: Change in cardiac function and reduced HF symptoms
Secondary	Therapy Safety: Continuous appropriate pacing
Secondary	Device Efficacy: Stable chronic LV thresholds, R-wave amplitudes and impedances from those not selected in final programming at six-months