HeartMate 3™ CE Mark Clinical Investigation Plan

Not Applicable

Completed

• Conditions: Advanced Refractory Left Ventricular Heart Failure
• Interventions: Device: Left Ventricular Assist System (LVAS)

• Registration Number: NCT02170363
• Lead Sponsor: Abbott Medical Devices

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Primary Completion: 2015-05
• Results First Submitted: 2017-04-21
• Results First Submitted QC: 2017-08-03
• Results First Posted: 2018-02-15
• Study Completion: 2020-03-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patient or legal representative has signed Informed Consent Form (ICF)

2. Age ≥ 18 years

3. BSA ≥ 1.2 m2

4. NYHA IIIB or IV OR ACC/AHA Stage D

5. LVEF ≤ 25%

6. CI ≤ 2.2 L/min/m2, while not on inotropes

7. 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

8. Females of child bearing age must agree to use adequate contraception

Exclusion Criteria

1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy

2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator

3. Existence of ongoing mechanical circulatory support (MCS) other than IABP

4. Positive pregnancy test if of childbearing potential

5. Lactating mothers

6. Presence of mechanical aortic cardiac valve that will not be converted to a bioprosthesis at the time of LVAD implant

7. History of any organ transplant

8. Platelet count < 100,000 x 103/L (< 100,000/ml)

9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management

10. History of confirmed, untreated AAA > 5 cm in diameter

11. Presence of an active, uncontrolled infection

12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status

13. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:

    1. An INR ≥ 2.5 not due to anticoagulation therapy
    2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
    3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 <50% predicted
    4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
    5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis
    6. Serum creatinine ≥221umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
    7. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration

14. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant

15. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL)

16. Planned Bi-VAD support prior to enrollment

17. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia

18. Participation in any other clinical investigation that is likely to confound study results or affect the study

19. Any condition other than HF that could limit survival to less than 24 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HeartMate 3	Left Ventricular Assist System (LVAS)	Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Functional Status - New York Heart Association (NYHA) Classification	Baseline, Month 1, Month 3, Month 6	NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Rehospitalizations	As they occurred, Baseline through 180 Days	Frequency and incidence of rehospitalizations
Stroke Free Survival	6 months	Percentage of participants free of debilitating stroke (Modified Rankin Score \> 3)
All Adverse Events	As they occurred, Baseline through 180 Days	Frequency of pre-defined anticipated adverse events
Quality of Life (EQ-5D-5L)	Baseline, Month 1, Month 3, Month 6	The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
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	Frequency and incidence of device malfunction
Reoperations	As they occurred, Baseline through 180 Days	Frequency of reoperations
Functional Status - Six Minute Walk Test (6MWT)	Baseline, Month 1, Month 3, Month 6	The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.

Trial Locations

Locations (10)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Institute for Clinical and Experimental Medicine (IKEM); 🇨🇿 Prague, Czechia

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Universitats-Herzzentrum Freiburg; 🇩🇪 Freiburg, Germany

Herz- und Diabeteszentrum NRW Thorax- und Kardiovaskularchirurgie Clinic; 🇩🇪 Bad Oeynhausen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Herzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

AKH Medical University of Vienna; 🇦🇹 Vienna, Austria

National Research Center for Cardiac Surgery; 🇰🇿 Astana, Kazakhstan

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia