Interventricular Delay of Lumax HF-T for Heart Failure

Completed · Phase 2

Conditions studied: Congestive Heart Failure

In brief

The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax HF-T with simultaneous biventricular pacing (SIM) in patients with heart failure requiring cardiac resynchronization therapy.

Key facts

Study ID

NCT00508391

Run by

Biotronik, Inc.

People needed

122

Starts

2007-07-01

Expected to finish

2009-08-01

Last updated by the study team

2010-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet the indications for therapy
• Successfully implanted with a BIOTRONIK Lumax HF-T CRT-D system and have received SIM for a minimum of 30 days prior to enrollment. A successful implantation is defined as having a measured LV pacing threshold which allows for a minimum 1-volt safety margin without any phrenic nerve stimulation at the time of enrollment.
• Treated with stable and optimal CHF medications, which includes an ACE inhibitor (ACE-I) or Angiotensin Receptor Blocker (ARB) at therapeutic dose for 1 month prior to enrollment, if tolerated, and a Beta Blocker that is approved and indicated for HF for 3 months prior to enrollment, if tolerated, with a stable dosage for 1 month prior to enrollment. If the patient is intolerant of ACE-I or beta blockers, documented evidence must be available. Eplerenone requires dosage stability for 1 month prior to enrollment. Diuretics may be used as necessary to keep the patient euvolemic. Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timeliness. Stable is defined as no more than a 100% increase or a 50% decrease in dose.
• Age ≥ 18 years
• Able to understand the nature of the study and give informed consent
• Able to complete all testing required by the clinical protocol, including the 6-minute walk test and QOL questionnaire
• Available for follow-up visits on a regular basis at the investigational site

You may not qualify if…

• Meet one or more of the contraindications
• Have a life expectancy of less than 6 months
• Expected to receive heart transplantation within 6 months
• Have had more than 1 CHF-related hospitalization within past 30 days
• Currently receiving IV inotropic medications
• Chronic atrial fibrillation
• Enrolled in another cardiovascular or pharmacological clinical investigation, except for FDA required post-market registries
• Any condition preventing the patient from being able to perform required testing
• Presence of another life-threatening, underlying illness separate from their cardiac disorder

Where it is running

• Solano Cardiology — Fairfield, California, United States
• Cardiac Arrhythmia Associates — La Jolla, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Cardiology Associates Medical Group — Ventura, California, United States
• Cardiac Disease Specialists, P.C. — Atlanta, Georgia, United States
• Georgia Arrhythmia Consultants — Macon, Georgia, United States
• Fananapazir — Cumberland, Maryland, United States
• St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Michigan Cardiovascular Institute — Saginaw, Michigan, United States
• SSM Medical Group — St Louis, Missouri, United States
• Gateway Cardiology — St Louis, Missouri, United States
• Salem Cardiology — Salem, Oregon, United States
• Palmetto Cardiology — Columbia, South Carolina, United States
• Pee Dee Cardiology — Florence, South Carolina, United States
• Cardiology Consultants — Spartanburg, South Carolina, United States
• Lone Star Heart Center — Amarillo, Texas, United States
• Cardiac Associates of Dallas — Dallas, Texas, United States
• Yakima Heart Center — Yakima, Washington, United States
• University Hospital Zurich — Zurich, Switzerland, Switzerland

Full record on ClinicalTrials.gov

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