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NCT05271214Recruiting

Conservative Management of Left Ventricular Assist Device Candidates

Source: ClinicalTrials.gov · Last updated 8 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
26 Feb 2022
Start date
1 Jan 2018
Primary completion date
Jan 2028
Lead sponsor
Tel-Aviv Sourasky Medical Center
NCT number
NCT05271214

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Jan 2018 to the primary completion date, Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • \- 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.

Who the study is looking for

  • \- 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.

Age in the registry: 18 years to 80 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tel-Aviv Sourasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.