HeartMate 3™ CE Mark Clinical Investigation Plan

NCT02170363 | Completed Results

• 1 other identifier: TC02212014
• Study Type: interventional
• Target: 50
• Locations: 5 countries
• Sites: 9

Brief Summary

The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol. This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).

Conditions

Advanced Refractory Left Ventricular Heart Failure

Keywords

Heart Failure; Ventricular Dysfunction; Cardiomyopathies; Heart Disease; Cardiovascular Disease; Heart-assist devices; Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• Survival

  Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data

  6 months

Secondary Outcomes (8)

• Quality of Life (EQ-5D-5L)

  Baseline, Month 1, Month 3, Month 6

• Functional Status - Six Minute Walk Test (6MWT)

  Baseline, Month 1, Month 3, Month 6

• Functional Status - New York Heart Association (NYHA) Classification

  Baseline, Month 1, Month 3, Month 6

• All Adverse Events

  As they occurred, Baseline through 180 Days

• Device Malfunctions

  As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome

Study Arms (1)

HeartMate 3

EXPERIMENTAL

Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure

Device: Left Ventricular Assist System (LVAS)

Interventions

Left Ventricular Assist System (LVAS) DEVICE

Implantation of left ventricular assist device for hemodynamic support

HeartMate 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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,
• \- 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,
• \- Inotrope dependent/unable to wean from inotropes
• \- Listed for Transplant
• Females of child bearing age must agree to use adequate contraception

You may not qualify if:

• Etiology of 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 that will not be converted to a bioprosthesis at the time of LVAD implant
• 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 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Center for Life Sciences: collaborator
• Emergo: collaborator
• KCRI: collaborator
• Thoratec Corporation: collaborator

Study Sites (10)

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

AKH Medical University of Vienna

Vienna, A-1090, Austria

Location

Toronto General Hospital

Toronto, Ontario, M5G-2C4, Canada

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 4, Czechia

Location

Herz- und Diabeteszentrum NRW Thorax- und Kardiovaskularchirurgie Clinic

Bad Oeynhausen, 32545, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Universitats-Herzzentrum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Herzentrum Leipzig GmbH

Leipzig, 04280, Germany

Location

National Research Center for Cardiac Surgery

Astana, 010000, Kazakhstan

Location

Related Publications (3)

• Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.

  PMID: 26670056 RESULT

• Schmitto JD, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Sood P, Damme L, Netuka I. Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study. Eur J Heart Fail. 2019 Jan;21(1):90-97. doi: 10.1002/ejhf.1284. Epub 2018 Jul 27.

  PMID: 30052304 DERIVED

• Krabatsch T, Netuka I, Schmitto JD, Zimpfer D, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Damme L, Pya Y. Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial. J Cardiothorac Surg. 2017 Apr 4;12(1):23. doi: 10.1186/s13019-017-0587-3.

  PMID: 28376837 DERIVED

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Poornima Sood
• Organization: St. Jude Medical

PSood@sjm.com

+17818528334

Study Officials

• Carlo Gazzola, B. Sc.

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: March 9, 2020
• Last Updated: June 27, 2022
• Results First Posted: February 15, 2018

Record last verified: 2022-06

Locations

AU (1); CZ (1); KA (1); DE (5); CA (1)