NCT03022461

Brief Summary

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 2, 2021

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

5.5 years

First QC Date

January 12, 2017

Results QC Date

March 1, 2021

Last Update Submit

June 23, 2022

Conditions

Advanced Refractory Left Ventricular Heart Failure

Keywords

Heart FailureVentricular DysfunctionCardiomyopathiesHeart DiseaseCardiovascular DiseaseHeart-assist DevicesThoratec Corporation

Outcome Measures

Primary Outcomes (1)

  • Survival

    Subject outcomes and survival over time

    At 5 years post HM3 CE Mark study implant

Secondary Outcomes (8)

  • EuroQoL 5D-5L (EQ-5D-5L) VAS Score

    At 5 years post HM3 CE Mark study implant

  • Six Minute Walk Test (6MWT)

    At 5 years post HM3 CE Mark study implant

  • New York Heart Association (NYHA)

    At 5 years post HM3 CE Mark study implant

  • Adverse Events

    Between 2 and 5 years post HM3 CE Mark study implant

  • Device Malfunctions

    Between 2 and 5 years post HM3 CE Mark study implant

  • +3 more secondary outcomes

Study Arms (1)

Ongoing HM3 CE Mark study patients

The study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.

Other: Long term follow-up

Interventions

Long term follow-upOTHER
Ongoing HM3 CE Mark study patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced refractory left ventricular heart failure who were implanted with HeartMate 3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up will be enrolled in this study.

You may qualify if:

  • Patient or legal representative has signed Informed Consent Form (ICF).
  • Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.

You may not qualify if:

  • \. Patient does not consent to the continued data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

The Alfred Hospital

Melbourne, Victoria, 3000, Australia

Location

AKH Medical University of Vienna

Vienna, A-1090, Austria

Location

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 4, Czechia

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Universitats-Herzzentrum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

National Research Center for Cardiac Surgery

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Heart FailureVentricular DysfunctionCardiomyopathiesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Poornima Sood
Organization
Abbott
poornima.sood@abbott.com
+17818528334

Study Officials

  • Carlo Gazzola, B. Sc.

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

June 23, 2014

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

June 27, 2022

Results First Posted

December 2, 2021

Record last verified: 2022-06

Locations

DE(3)CZ(1)AU(1)CA(1)KA(1)