Sacramento, CANCT06526195Now EnrollingIRB Ready

Heart Failure Clinical Trial in Sacramento, CA

Access cutting-edge heart failure treatment through this clinical trial at a research site in Sacramento. Study-provided care at no cost to qualified participants.

Sponsored by Abbott Medical Devices

Quick Self-Assessment

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Expert Care in Sacramento

Access heart failure specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related heart failure treatment provided free

Apply for This Sacramento Location

Check if you qualify for this heart failure clinical trial in Sacramento, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Sacramento

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Sacramento site if eligible
  4. 4Begin participation

About This Heart Failure Study in Sacramento

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

Sponsor: Abbott Medical Devices

Who Can Participate

Inclusion Criteria

Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value)
NYHA Class IIIB or NYHA Class IV
Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group Randomization Criteria:
Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
mean PAP ≥ 30 mmHg.
The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant. Single Arm Registry Criteria:
Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.
Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
mean PAP \<30 mmHg

Exclusion Criteria

Subject is \< 18 years of age at the time of informed consent.
Dependent on IV inotrope in the last 30 days.
Contra-indications to HM3 LVAS or CardioMEMS HF system.
Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
Existence of ongoing MCS.
Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
History of any solid organ transplant.
Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
Presence of an active, uncontrolled infection.
Complex congenital heart disease.
Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis.
Planned VAD or Bi-VAD support prior to enrollment.
Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:
An INR ≥ 2.0 not due to anticoagulation therapy
An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
Biopsy proven liver cirrhosis.
Need for chronic renal replacement therapy.
History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted.
History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis.
Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.
Any condition other than HF that could limit survival to less than 24 months.
Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Sacramento?

Yes, this clinical trial (NCT06526195) has an active research site in Sacramento, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure Treatment Options in Sacramento, CA

If you're searching for heart failure treatment options in Sacramento, CA, this clinical trial (NCT06526195) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Sacramento research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure clinical trials near you to find additional studies recruiting in your area.

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Secure · Expert Care · Sacramento, CA