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Mechanical Circulatory Support Device

HeartMate 3 for Heart Failure (HM3 CE Mark Trial)

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 1, month 3, month 6
Awards & highlights

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).

Eligible Conditions
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 1, month 3, month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, month 3, month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival
Secondary outcome measures
All Adverse Events
Device Malfunctions
Functional Status - New York Heart Association (NYHA) Classification
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HeartMate 3Experimental Treatment1 Intervention
Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Left Ventricular Assist System (LVAS)
2014
N/A
~250

Find a Location

Who is running the clinical trial?

KCRIOTHER
24 Previous Clinical Trials
3,384 Total Patients Enrolled
1 Trials studying Heart Failure
115 Patients Enrolled for Heart Failure
EmergoUNKNOWN
Thoratec CorporationIndustry Sponsor
22 Previous Clinical Trials
3,199 Total Patients Enrolled
15 Trials studying Heart Failure
2,420 Patients Enrolled for Heart Failure
~5 spots leftby Jul 2025
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