Pacing for Heart Failure With Preserved Ejection Fraction (HFpEF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01045291
First received: January 8, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. This new pacing method may allow the heart to pump more efficiently. Participation in this study will last approximately 8 months.


Condition Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pacing for Heart Failure With Preserved Ejection Fraction

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Number of adverse events while the Fusion Pacing download is active vs. inactive. [ Time Frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit ] [ Designated as safety issue: No ]
  • Percentage of time the Fusion Pacing is active throughout a four-month follow-up period. [ Time Frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Minnesota Living with Heart Failure Questionnaire score. [ Time Frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit ] [ Designated as safety issue: No ]
  • Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX). [ Time Frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit ] [ Designated as safety issue: No ]
  • Change in echocardiography measures: E/E', Ejection Fraction, LV EDV. [ Time Frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit ] [ Designated as safety issue: No ]
  • Change in NT-proBNP. [ Time Frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fusion Pacing OFF
Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF. At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm.
Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Other Names:
  • Fusion Pacing Investigational Software
  • Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.
Experimental: Fusion Pacing ON
Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON. At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm.
Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
Other Names:
  • Fusion Pacing Investigational Software
  • Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.

Detailed Description:

Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature. When the feature is active, the device wil pace the left ventricle to target improved pump efficiency. Patients will have the feature active for 4 months and inactive for 4 months. The order will be randomized and the patient will not know whether the pacing is active or not. Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with quantitative ejection fraction (EF) of greater than 50 percent
  • Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
  • Patients greater than 18 years of age
  • Patients willing and able to give informed consent
  • Patients available for appropriate follow-up times for the length of study
  • Patients able to complete cardiopulmonary exercise (CPX) testing
  • Patients expected lifespan is greater than 12 months beyond study enrollment
  • Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds

Exclusion Criteria:

  • Patients who have undergone cardiac surgery 60 days prior to enrollment
  • Patients who have had a myocardial infarction 90 days prior to enrollment
  • Patients with hemodynamically significant uncorrected cardiac valvular disease
  • Patients with active myocarditis and amyloidosis (if documented)
  • Patients with a permanent pacemaker
  • Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
  • Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
  • Patients with a PR interval greater than 250 milliseconds
  • Patients with severe chronic obstructive pulmonary disease
  • Patients with high risk coronary artery disease
  • Patients who are or expect to become pregnant during this study
  • Patients enrolled in concurrent studies which could confound the results of this study
  • Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
  • Patients with infiltrative disease or restrictive cardiomyopathy
  • Patients with indication for percutaneous coronary intervention (PCI) at enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045291

Locations
Belgium
Aalst, Belgium
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: HFpEF Trial Leader Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01045291     History of Changes
Other Study ID Numbers: MDT0095101
Study First Received: January 8, 2010
Last Updated: May 29, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Taiwan: Department of Health

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014