Congestive Heart FailurePhase 2/3NCT00158951
Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF
A Phase 2/3 study testing CONTAK RENEWAL 2/4/4HE CRT-D and EASYTRAK 2 Lead in people with Congestive Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- CONTAK RENEWAL 2/4/4HE CRT-D and EASYTRAK 2 Lead
- Type of treatment
- Medical device
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Oct 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead
- Keywords
- Left Ventricular Lead, Cardiac Resynchronization Therapy, Congestive Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTAK RENEWAL 2/4/4HE CRT-DDevice
EASYTRAK 2 LeadDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158951
- Sponsor's protocol ID
- Clinicals0005
- Status last verified
- Jun 2007
- First submitted
- 8 Sep 2005
- Last updated
- 25 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00158951
- Acronym / sponsor ID
- Clinicals0005
- Conditions
- Congestive Heart Failure
- Keywords
- Left Ventricular Lead, Cardiac Resynchronization Therapy, Congestive Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Oct 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONTAK RENEWAL 2/4/4HE CRT-D | Device | – |
| EASYTRAK 2 Lead | Device | – |
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CONTAK RENEWAL 2/4/4HE CRT-D and EASYTRAK 2 Lead in people with Congestive Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapy Efficacy: Change in cardiac function at six-months. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2007; AzTrials last refreshed its copy on 27 Oct 2026.