Pacing for Heart Failure With Preserved Ejection Fraction

NCT01045291 | Completed

• 1 other identifier: MDT0095101
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Number of adverse events while the Fusion Pacing download is active vs. inactive.

  From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

• Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.

  From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

Secondary Outcomes (4)

• Change in Minnesota Living with Heart Failure Questionnaire score.

  From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

• Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).

  From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

• Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.

  From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

• Change in NT-proBNP.

  From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit

Study Arms (2)

Fusion Pacing OFF

ACTIVE COMPARATOR

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)

Fusion Pacing ON

EXPERIMENTAL

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)

Interventions

Cardiac Resynchronization Therapy-Defibrillator (CRT-D) DEVICE

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.

Also known as: Fusion Pacing Investigational Software, Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.

Fusion Pacing OFF; Fusion Pacing ON

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

Unknown Facility

Aalst, Belgium

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• HFpEF Trial Leader

  Medtronic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

BE (1); TW (1)