Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697980
Other study ID # Apogee
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 17, 2019
Est. completion date February 10, 2022

Study information

Verified date November 2023
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

The Apogee study is a prospective, observational, post-market, on-label, multi-site study in Destination Therapy patients. Patients participating in the Medtronic Destination Therapy (DT) Post Approval Study (PAS) (NCT03681210) are eligible for participation in Apogee. Patients enrolled in Apogee will be followed under the Apogee study for one-year post-implant. After participation in Apogee ends, patients will remain enrolled in DT PAS and will continue to be followed as outlined in the DT PAS protocol. The total estimated study duration is 33 months.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date February 10, 2022
Est. primary completion date February 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects consented to participate in DT PAS are eligible for participation in Apogee. Exclusion Criteria: - There are no exclusion criteria unique to Apogee.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HeartWare Ventricular Assist 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).

Locations

Country Name City State
United States University of Colorado Aurora Colorado
United States The Johns Hopkins Hospital Baltimore Maryland
United States University of Maryland Medical Center Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Northwestern University Chicago Illinois
United States The Lindner Christ Hospital Cincinnati Ohio
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States Baylor College of Medicine Houston Texas
United States Houston Methodist Hospital Houston Texas
United States University of Texas Health Sciences Center Houston Texas
United States The University of Kansas Medical Center Kansas City Kansas
United States Saint Vincent Heart Clinic Arkansas Little Rock Arkansas
United States University of Louisville Louisville Kentucky
United States Vanderbilt University Medical Center Nashville Tennessee
United States Columbia University New York New York
United States NYU Langone Medical Center New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Cardiac Surgery Clinical Research Center Oak Lawn Illinois
United States AdventHealth Orlando Florida
United States University of Pittsburgh Medical Center UPMC Presbyterian Pittsburgh Pennsylvania
United States Providence St. Vincent Medical Center Portland Oregon
United States Virginia Commonwalth University Health System Richmond Virginia
United States Mayo Clinic Rochester Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States University of California San Diego San Diego California
United States University of California San Francisco Medical Center San Francisco California
United States University of Washington Medical Center Seattle Washington
United States Stanford University Hospital Stanford California
United States Oklahoma Heart Institute Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03597646 - The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure N/A
Terminated NCT04065997 - Apogee International
Withdrawn NCT03675113 - Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure N/A
Completed NCT02916160 - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study Phase 4
Completed NCT03126656 - Effects of Testosterone on Myocardial Repolarization Phase 4
Completed NCT02247245 - The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. N/A
Completed NCT02268500 - VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) Phase 4
Completed NCT01919918 - Muscle Afferent Feedback Effects in Patients With Heart Failure Phase 1
Terminated NCT01906957 - Cognition and Exercise Training N/A
Not yet recruiting NCT01669395 - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial N/A
Completed NCT00984529 - Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia N/A
Recruiting NCT00863421 - Sleep Disordered Breathing in Patients With Chronic Heart Failure N/A
Completed NCT02840565 - Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 Phase 1
Completed NCT02441218 - Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study Phase 3
Completed NCT00149409 - Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure Phase 2/Phase 3
Terminated NCT05532046 - A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) Phase 1
Recruiting NCT04984928 - Readmission Risk of Patients With Heart Failure.
Completed NCT02814097 - A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction Phase 2
Active, not recruiting NCT05560737 - ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Recruiting NCT03286127 - Palliative Outcome Evaluation Muenster I