Interventricular Delay of Lumax HF-T for Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508391
• Other study ID #: G070019
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2007
• Last updated: January 21, 2010
• Start date: July 2007
• Est. completion date: August 2009

Study information

• Verified date: January 2010
• Source: Biotronik, Inc.
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Optimized interventricular delay biventricular pacing
Lumax HF-T with optimized interventricular delay biventricular pacing

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Classified as "Not Worsened" for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing		60 days after enrollment	No
Primary	Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device		60 days after enrollment	Yes