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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697980
Recruitment Status : Active, not recruiting
First Posted : October 5, 2018
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date October 4, 2018
First Posted Date October 5, 2018
Last Update Posted Date June 14, 2021
Actual Study Start Date January 17, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2018)
Rate of major adverse events [ Time Frame: Implant to 12 months ]
Major adverse events are defined to be occurrence of infection, bleeding, device malfunction, stroke or death.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
Official Title Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
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.

Detailed 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Chronic Heart Failure
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).
Other Name: HVAD
Study Groups/Cohorts HVAD
Intervention: Device: HeartWare Ventricular Assist Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 3, 2021)
124
Original Estimated Enrollment
 (submitted: October 4, 2018)
100
Estimated Study Completion Date April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03697980
Other Study ID Numbers Apogee
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date June 2021