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

Advanced Refractory Left Ventricular Heart Failure Clinical Trial

— SWIFT  

Official title:

Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548128
• Other study ID #: ABT-CIP-10335VerC
• Status: Completed
• Start date: November 17, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: January 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 20, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Subject or Legal Representative has provided written informed consent by signing the study Informed Consent Form (ICF)

2. Subject must be = 18 years of age at the time of informed consent

3. Subject is receiving the HM3 as their first LVAD

4. Body surface area (BSA) = 1.2m2

5. Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV

6. LVEF = 25%

7. Subject is:

1. Inotrope dependent OR

2. 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

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

1. Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc)

2. Subject has greater than mild aortic insufficiency

3. Physiologically significant (i.e. requires intervention) atrial septal defect

4. Subject has severe right heart failure (RHF) (refer to Appendix 2 for guidance)

5. Subject has planned Bi-VAD support prior to enrollment

6. Presence of mechanical aortic valve that will not be either converted to bioprosthesis or oversewn at the time of LVAD implant

7. Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP

8. Subject has a history of any organ transplant

9. Positive pregnancy test

10. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy

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

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

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

14. History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment

15. Presence of an active, uncontrolled infection

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

17. Presence of any one of the following risk factors for indications of severe end organ

dysfunction or failure:

1. An INR = 2.0 not due to anticoagulation therapy

2. Total bilirubin > 43 µmol/L (2.5 mg/dl) or biopsy-proven liver cirrhosis

3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted

4. Fixed pulmonary hypertension with 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%) uncorrected carotid stenosis

6. Serum creatinine = 221 µmol/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

18. Pre-albumin < 150mg/liter (15 mg/dl) or albumin <30 g/liter (3g/dl) (if only one available); pre-albumin <150mg/liter (15 mg/dl) and albumin <30 g/liter (3 g/dl) (if both available)

19. Subject has known hypo- or hyper-coagulable states such as disseminated intravascular coagulation and heparin-induced thrombocytopenia

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

Related Conditions & MeSH terms

• Advanced Refractory Left Ventricular Heart Failure
• Heart Failure

Intervention

Device:
• HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Coloardo Hospital	Aurora	Colorado
United States	Cardiothoracic & Vascular Surgeons	Austin	Texas
United States	Tufts Medical Center	Boston	Massachusetts
United States	Medical College of South Carolina	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Shands at the University of Florida	Gainesville	Florida
United States	Spectrum Health Butterworth Hospital	Grand Rapids	Michigan
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	St. Vincent Medical Group	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Baptist Health Medical Center	Little Rock	Arkansas
United States	University of Wisconsin	Madison	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Mount Sinai Hosptial	New York	New York
United States	New York-Presbyterian/Columbia University Medical Center	New York	New York
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	AdventHealth Orlando	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Methodist Healthcare System of San Antonio	San Antonio	Texas
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Stay	Mean length of hospital stay from implant to hospital discharge	Initial hospital stay, approximately 3 weeks