NCT05271214 Conservative Management of Left Ventricular Assist Device Candidates
| NCT ID | NCT05271214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tel-Aviv Sourasky Medical Center |
| Condition | Advanced Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2018-01-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Left ventricular assist device (LVAD) candidates will be comprehensively evaluated at our center, including clinical evaluation, echocardiography, right heart catheterization, cardiopulmonary exercise test and laboratory exams. following this evaluation, patients will be treated with inotropes, diuretics, uptitrated neurohormonal therapy. vitamin and iron deficiencies will be corrected and the patients will be referred for coronary interventions and cardiac resynchronization therapy appropriately. The need for LVAD implantation will be reevaluated according to the patient's clinical condition, echocardiography and laboratory findings.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05271214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Advanced Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05271214 currently recruiting?
Yes, NCT05271214 is actively recruiting participants. Contact the research team at oferh@tlvmc.gov.il for enrollment information.
Where is the NCT05271214 trial being conducted?
This trial is being conducted at Tel Aviv, Israel.
Who is sponsoring the NCT05271214 clinical trial?
NCT05271214 is sponsored by Tel-Aviv Sourasky Medical Center. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.