Management of patients with advanced heart failure who may need a left ventricular assist device
Official title: Conservative Management of Left Ventricular Assist Device Candidates
Run by Tel-Aviv Sourasky Medical Center · NCT05271214 · Data updated 2026-11-12
This study tests how to best manage patients with advanced heart failure who might need a heart pump to see if personalized treatments can help them feel better and avoid surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Drugs / interventions | Cart |
| Locations | 1 site (Tel Aviv) |
| Status | Recruiting |
| Started | January 1, 2018 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | March 8, 2022 |
| Trial ID | NCT05271214 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with advanced heart failure, characterized by severe left ventricular dysfunction and significant symptoms.
✕Probably not a fit
Patients with advanced liver or kidney disease, severe pulmonary or vascular disease, or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates patients with advanced heart failure who are candidates for left ventricular assist device (LVAD) implantation. Participants undergo a comprehensive cardiac assessment, including echocardiography, right heart catheterization, and exercise testing, to determine their clinical status and need for LVAD. Following this evaluation, patients receive individualized medical therapy aimed at stabilizing their condition, with ongoing assessments to monitor their progress and reevaluate the necessity for LVAD implantation. The study aims to optimize treatment for heart failure patients and improve their overall outcomes.
Why it matters
Potential benefit: If successful, this approach could enhance the management of advanced heart failure and potentially delay or prevent the need for LVAD implantation.
How similar studies have gone: While similar approaches have been explored, this specific management protocol for LVAD candidates is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- left ventricular ejection fraction \<35%. New York Heart Association Class III or IV. Brain natriuretic peptide levels \> 450pg/ml. Heart failure hospitalization in the past 6 months. Maximal oxygen consumption \< 12 ml/kg/min. Intolerant to conventional heart failure therapy. Exclusion Criteria: \- Special populations - pregnant, unable to give informed consent. Advanced liver disease (Child Pugh class B or C). Advanced kidney disease (eGFR\<30ml/min). Severe pulmonary disease. Severe peripheral vascular disease. Active malignancy.
Where it's running
-
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel Recruiting
Study contacts
- Study coordinator: Ofer Havakuk, MD
- Email: oferh@tlvmc.gov.il
- Phone: +97236974250
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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First-in-human flow-based heart support device for advanced heart failure
A first-in-human trial is testing the Icoms FlowMaker, a wireless implantable heart assist device, in adults with advanced heart failure who are at high risk for traditional LVAD or driveline options.
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GDF-15 levels to predict early outcomes after LVAD implantation
We will see if pre-surgery blood levels of GDF-15 can predict early complications or death in adults having an LVAD implanted.
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Tiered Palliative Care for Patients with Advanced Heart Failure or Cancer
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First-in-human CorWave LVAS for advanced heart failure
This trial will test a new CorWave left ventricular assist system (LVAS) in adults with advanced heart failure who are eligible for heart transplantation.
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Understanding what to expect after getting a Ventricular Assist Device
This study is trying to help patients understand what to expect after getting a Ventricular Assist Device for heart failure, so they can feel more at ease and improve their quality of life.
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Palliative care for patients with advanced heart failure or cancer
This study is testing a new palliative care program for people with advanced heart failure or cancer to see if it can improve their quality of life and reduce hospital visits compared to standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.