NCT02475460

Brief Summary

The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable heart-failure

Geographic Reach
2 countries

3 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

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 11, 2015

Last Update Submit

June 23, 2022

Conditions

Heart FailureCardiovascular Disease

Keywords

HeartMate 3LVASLVADHeart-assist DevicesAdvancedVentricular Dysfunctionrefractory left ventricularThoratec Corporation

Outcome Measures

Primary Outcomes (1)

  • Number of survival participants

    30 days

Study Arms (1)

HM 3 LIS

EXPERIMENTAL

All patients implanted with the HM 3 LVAD via less invasive surgical technique

Procedure: Less Invasive Surgery (LIS)Device: HeartMate 3™

Interventions

Less Invasive Surgery (LIS)PROCEDURE

Less invasive HM 3 LVAD surgical implant procedure

HM 3 LIS
HeartMate 3™DEVICE

HM 3 LIS

HM 3 LIS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient or legal representative has signed Informed Consent Form (ICF)
  • Age ≥ 18 years
  • BSA ≥ 1.2 m2
  • NYHA IIIB or IV, or ACC/AHA Stage D
  • LVEF ≤ 25%
  • CI ≤ 2.2 L/min/m2, while not on inotropes (if Patient is treated with inotropes at baseline, this does not apply)
  • Patients must also meet one of the following:
  • On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond, OR
  • In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days, OR
  • Inotrope dependent/unable to wean from inotropes OR
  • Listed for transplant
  • Females of child bearing age must agree to use adequate contraception-

You may not qualify if:

  • Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
  • Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator
  • Existence of ongoing mechanical circulatory support (MCS) other than IABP
  • Positive pregnancy test if of childbearing potential
  • Lactating mothers
  • Presence of mechanical aortic cardiac valve
  • History of any organ transplant
  • Platelet count \< 100,000 x 103/L (\< 100,000/ml)
  • Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
  • History of confirmed, untreated AAA \> 5 cm in diameter
  • Presence of an active, uncontrolled infection
  • Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the Investigator will require based upon the patients' health status
  • Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
  • An INR ≥ 2.5 not due to anticoagulation therapy
  • Total bilirubin \> 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 4, Czechia

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Heart FailureCardiovascular DiseasesVentricular Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Sami Somo

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 18, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations

CZ(1)DE(2)