Interventricular Delay of Lumax HF-T for Heart Failure

NCT00508391 | Completed Phase 2 Results

• 1 other identifier: G070019
• Study Type: interventional
• Target: 122
• Locations: 2 countries
• Sites: 19

Brief 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.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

  The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified "not worsened" if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105.

  60 days after enrollment

• 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

  The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device. These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.

  60 days after enrollment

Study Arms (2)

Simultaneous 1st, Optimized 2nd

EXPERIMENTAL

Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.

Device: Optimized interventricular delay biventricular pacing

Optimized 1st, Simultaneous 2nd

EXPERIMENTAL

Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.

Device: Optimized interventricular delay biventricular pacing

Interventions

Optimized interventricular delay biventricular pacing DEVICE

Lumax HF-T with optimized interventricular delay biventricular pacing

Also known as: Optimized CRT, Interventricular delay

Optimized 1st, Simultaneous 2nd; Simultaneous 1st, Optimized 2nd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (19)

Solano Cardiology

Fairfield, California, 94533, United States

Location

Cardiac Arrhythmia Associates

La Jolla, California, 92307, United States

Location

Sansum Clinic

Santa Barbara, California, 93110, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Cardiac Disease Specialists, P.C.

Atlanta, Georgia, 30309, United States

Location

Georgia Arrhythmia Consultants

Macon, Georgia, 31201, United States

Location

Fananapazir

Cumberland, Maryland, 21502, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Michigan Cardiovascular Institute

Saginaw, Michigan, 48601, United States

Location

SSM Medical Group

St Louis, Missouri, 63117, United States

Location

Gateway Cardiology

St Louis, Missouri, 63128, United States

Location

Salem Cardiology

Salem, Oregon, 97302, United States

Location

Palmetto Cardiology

Columbia, South Carolina, 29204, United States

Location

Pee Dee Cardiology

Florence, South Carolina, 29505, United States

Location

Cardiology Consultants

Spartanburg, South Carolina, 29303, United States

Location

Lone Star Heart Center

Amarillo, Texas, 79106, United States

Location

Cardiac Associates of Dallas

Dallas, Texas, 75230, United States

Location

Yakima Heart Center

Yakima, Washington, 98902, United States

Location

University Hospital Zurich

Zurich, Switzerland, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clay Cohorn
• Organization: BIOTRONIK, Inc.

clay.cohorn@biotronik.com

503-387-2614

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: January 26, 2010
• Results First Posted: January 18, 2010

Record last verified: 2010-01

Locations

US (18); CH (1)