Interventricular Delay of Lumax HF-T for Heart Failure

Biotronik

Status and phase

Completed

Phase 2

Conditions

Congestive Heart Failure

Treatments

Device: Optimized interventricular delay biventricular pacing

Study type

Interventional

Funder types

Industry

Identifiers

NCT00508391

G070019

Details and patient eligibility

About

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.

Full description

This study is a randomized, double-blinded, crossover, multi-center, prospective trial. The study will consist of up to 122 subjects who require treatment of advanced heart failure through cardiac resynchronization therapy (CRT) with back-up defibrillation capabilities. Eligible patients will have a successfully implanted BIOTRONIK Lumax HF-T CRT-D system and have received simultaneous biventricular pacing for a minimum of 90 days prior to enrollment. The 90-day period is being required to allow the treatment effect of CRT therapy with SIM to be complete and to ensure the patient is receiving a stable and optimal CHF medical regimen. The patients will have the interventricular delay feature programmed after a standardized optimization procedure. Patients, along with study personnel evaluating the study endpoint measures, will be blinded to the type of CRT therapy delivered during the study follow-up period.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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