Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS

NCT04548128 | Completed

• 1 other identifier: ABT-CIP-10335VerC
• Study Type: observational
• Target: 102
• Locations: 2 countries
• Sites: 32

Brief Summary

This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS). The objective of this study is to evaluate the implantation of the HM3 utilizing techniques other than full median sternotomy (e.g. thoracotomy) and impact on post-implant length of stay.

Conditions

Advanced Refractory Left Ventricular Heart Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients surviving at 6 months free of debilitating stroke (Modified Rankin Score > 3), device malfunction requiring re-operation to replace or remove the device, or conversion of the implant surgical approach to open sternotomy.

  The composite primary endpoint of the study is survival at 6 months free of debilitating stroke (Modified Rankin Score \> 3), device malfunction requiring re-operation to replace or remove the device, or conversion of the implant surgical approach to open sternotomy.

  6 Months

Secondary Outcomes (1)

• Length of Stay

  Initial hospital stay, approximately 3 weeks

Study Arms (1)

Treatment Arm

The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy).

Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)

Interventions

HeartMate 3 Left Ventricular Assist System (HM3 LVAS) DEVICE

This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects from the general heart failure population.

You may qualify if:

• Subject or Legal Representative has provided written informed consent by signing the study Informed Consent Form (ICF)
• Subject must be ≥ 18 years of age at the time of informed consent
• Subject is receiving the HM3 as their first LVAD
• Body surface area (BSA) ≥ 1.2m2
• Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
• LVEF ≤ 25%
• Subject is:
• Inotrope dependent OR
• Has CI\<2.2 L/min/m2, while not on inotropes and meets one of the following criteria:
• On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond to therapy
• Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days
• Females of child bearing age must agree to use adequate contraception

You may not qualify if:

• Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc)
• Subject has greater than mild aortic insufficiency
• Physiologically significant (i.e. requires intervention) atrial septal defect
• Subject has severe right heart failure (RHF) (refer to Appendix 2 for guidance)
• Subject has planned Bi-VAD support prior to enrollment
• Presence of mechanical aortic valve that will not be either converted to bioprosthesis or oversewn at the time of LVAD implant
• Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP
• Subject has a history of any organ transplant
• Positive pregnancy test
• 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
• 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 within 6 months of enrollment
• Presence of an active, uncontrolled infection

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (32)

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

University of Coloardo Hospital

Aurora, Colorado, 80045, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

St. Vincent Medical Group

Indianapolis, Indiana, 46260, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66106, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Mount Sinai Hosptial

New York, New York, 10029, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical College of South Carolina

Charleston, South Carolina, 29425, United States

Location

Cardiothoracic & Vascular Surgeons

Austin, Texas, 78756, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78201, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99202, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Study Officials

• Sami Somo, PhD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: September 14, 2020
• Study Start: November 17, 2020
• Primary Completion: July 19, 2022
• Study Completion: December 20, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (31); CA (1)