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Interventricular Delay of Lumax HF-T for Heart Failure

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Optimized interventricular delay biventricular pacing
Sponsored by
Biotronik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Solano Cardiology
  • Cardiac Arrhythmia Associates
  • Sansum Clinic
  • Cardiology Associates Medical Group
  • Cardiac Disease Specialists, P.C.
  • Georgia Arrhythmia Consultants
  • Fananapazir
  • St. Elizabeth's Medical Center
  • Michigan Cardiovascular Institute
  • SSM Medical Group
  • Gateway Cardiology
  • Salem Cardiology
  • Palmetto Cardiology
  • Pee Dee Cardiology
  • Cardiology Consultants
  • Lone Star Heart Center
  • Cardiac Associates of Dallas
  • Yakima Heart Center
  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Simultaneous 1st, Optimized 2nd

Optimized 1st, Simultaneous 2nd

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2007
Last Updated
January 21, 2010
Sponsor
Biotronik, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00508391
Brief Title
Interventricular Delay of Lumax HF-T for Heart Failure
Official Title
Clinical Investigation to Study Safety and Efficacy of the Interventricular Delay Feature of the Lumax HF-T Device for Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biotronik, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simultaneous 1st, Optimized 2nd
Arm Type
Experimental
Arm Description
Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
Arm Title
Optimized 1st, Simultaneous 2nd
Arm Type
Experimental
Arm Description
Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
Intervention Type
Device
Intervention Name(s)
Optimized interventricular delay biventricular pacing
Other Intervention Name(s)
Optimized CRT, Interventricular delay
Intervention Description
Lumax HF-T with optimized interventricular delay biventricular pacing
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
60 days after enrollment
Title
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
Description
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.
Time Frame
60 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Solano Cardiology
City
Fairfield
State/Province
California
ZIP/Postal Code
94533
Country
United States
Facility Name
Cardiac Arrhythmia Associates
City
La Jolla
State/Province
California
ZIP/Postal Code
92307
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
Cardiology Associates Medical Group
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Cardiac Disease Specialists, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Georgia Arrhythmia Consultants
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Fananapazir
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Michigan Cardiovascular Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
SSM Medical Group
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Gateway Cardiology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Salem Cardiology
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Facility Name
Palmetto Cardiology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Pee Dee Cardiology
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29505
Country
United States
Facility Name
Cardiology Consultants
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Lone Star Heart Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Cardiac Associates of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Yakima Heart Center
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
University Hospital Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

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Interventricular Delay of Lumax HF-T for Heart Failure

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