Management of patients with advanced heart failure who may need a left ventricular assist device
Conservative Management of Left Ventricular Assist Device Candidates
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Drugs / interventions | Cart |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT05271214 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with advanced heart failure, characterized by severe left ventricular dysfunction and significant symptoms.
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.
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 performed: While similar approaches have been explored, this specific management protocol for LVAD candidates is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Tel Aviv
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Ofer Havakuk, MD
- Email: oferh@tlvmc.gov.il
- Phone: +97236974250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.