Advanced Refractory Left Ventricular Heart FailureSWIFTNCT04548128
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
An observational study of Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 32 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Refractory Left Ventricular Heart Failure
- What is being tested?
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 17 Nov 2020to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects from the general heart failure population.
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the subjects' health status
- Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- An INR ≥ 2.0 not due to anticoagulation therapy
- Total bilirubin > 43 μmol/L (2.5 mg/dl) or biopsy-proven liver cirrhosis
- History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
- Fixed pulmonary hypertension with most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
- History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
- Serum creatinine ≥ 221 μmol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
- Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
- 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)
- Subject has known hypo- or hyper-coagulable states such as disseminated intravascular coagulation and heparin-induced thrombocytopenia
- Participation in any other clinical investigation that is likely to confound study results or affect the study
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Coloardo Hospital
Aurora, Colorado, 80045
Cardiothoracic & Vascular Surgeons
Austin, Texas, 78756
Tufts Medical Center
Boston, Massachusetts, 02111
Medical College of South Carolina
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27705
Shands at the University of Florida
Gainesville, Florida, 32610
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 49503
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
St. Vincent Medical Group
Indianapolis, Indiana, 46260
Kansas University Medical Center
Kansas City, Kansas, 66106
Baptist Health Medical Center
Little Rock, Arkansas, 72205
University of Wisconsin
Madison, Wisconsin, 53792
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Ochsner Medical Center
New Orleans, Louisiana, 70121
Mount Sinai Hosptial
New York, New York, 10029
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center
Omaha, Nebraska, 68198
AdventHealth Orlando
Orlando, Florida, 32803
Stanford University Medical Center
Palo Alto, California, 94304
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Rochester Medical Center
Rochester, New York, 14642
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78201
Sacred Heart Medical Center
Spokane, Washington, 99202
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy
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.
- Being tested
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy). Receives: Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (1)
Length of Stay
Mean length of hospital stay from implant to hospital discharge
Measured: Initial hospital stay, approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start17 Nov 2020
- Primary completion19 Jul 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Refractory Left Ventricular Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sami Somo, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548128
- Sponsor's protocol ID
- ABT-CIP-10335VerC
- Acronym
- SWIFT
- Status last verified
- Jan 2023
- First submitted
- 19 Jun 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy
- ClinicalTrials.gov ID
- NCT04548128
- Acronym / sponsor ID
- SWIFT / ABT-CIP-10335VerC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | – | Device: HeartMate 3 Left Ventricular Assist System (HM3 LVAS)The treatment arm will have the HM3 LVAS implanted utilizing a technique other than full median sternotomy (e.g. thoracotomy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects from the general heart failure population.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS)This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy. | Device | Treatment Arm |
Primary outcome
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.
Time frame: 6 Months
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.
1 secondary outcome
Length of Stay
Time frame: Initial hospital stay, approximately 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sami Somo, PhD study director
Abbott
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.