Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform

NCT03697980 | Completed Results FDA Device

• 1 other identifier: Apogee
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 33

Brief Summary

Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy. The Apogee study is conducted within Medtronic's Product Surveillance Platform.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Rate of Major Adverse Events

  Freedom from event is the probability (expressed as a percent of 100) the participant did not have a major adverse event during 12 months post implant via the Kaplan-Meier method. Participants that did not have a major adverse event were censored at the time of last follow-up in Apogee or their end of study at 12 months post implant, whichever occurred first. Major adverse events are defined to be occurrence of infection, bleeding, device malfunction, CT confirmed stroke, or death. Infection, bleeding, device malfunction and CT confirmed stroke were categorized via Intermacs Version 5.0. Events occurring during the implant procedure were excluded.

  Implant to 12 months

Study Arms (1)

HVAD Left Ventricular Assist Device

Device: HeartWare Ventricular Assist Device Other Names: HVAD The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).

Device: HeartWare Ventricular Assist Device

Interventions

HeartWare Ventricular Assist Device DEVICE

The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).

Also known as: HVAD

HVAD Left Ventricular Assist Device

Eligibility Criteria

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

Study Population

Patients enrolled in DT PAS (NCT03681210) are eligible for enrollment into Apogee and must be consented on the separate Apogee consent. It is expected that the Apogee cohort will be comprised of approximately 100 patients.

You may qualify if:

• Subjects consented to participate in DT PAS are eligible for participation in Apogee.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (33)

Saint Vincent Heart Clinic Arkansas

Little Rock, Arkansas, 72205, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Stanford University Hospital

Stanford, California, 94305-5330, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

AdventHealth

Orlando, Florida, 32804, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Cardiac Surgery Clinical Research Center

Oak Lawn, Illinois, 60453, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

The Lindner Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Sciences Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwalth University Health System

Richmond, Virginia, 23298, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Results Point of Contact

• Title: CRM/MCS Clinical Team
• Organization: Medtronic Cardiac Rhythm and Heart Failure

MedtronicCRMtrials@medtronic.com

800-328-2518

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: January 17, 2019
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: December 4, 2023
• Results First Posted: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)