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Clinical Investigation to Study Safety and Efficacy of the Interventricular Delay Feature of the Lumax HF-T Device for Heart Failure.

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Trial Conditions
  • Congestive Heart Failure
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Trial Interventions
Device
  • Optimized interventricular delay biventricular pacing
Other Information

Sponsor: Biotronik, Inc.
Phase: Phase 2
Trial ID: NCT00508391
Volunteers:  Not Accepting Healthy Volunteers

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