NCT05271214

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2018Jan 2028

Study Start

First participant enrolled

January 1, 2018

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

10 years

First QC Date

February 26, 2022

Last Update Submit

February 26, 2022

Conditions

Advanced Heart Failure

Outcome Measures

Primary Outcomes (1)

  • New York Heart Association (NYHA) Class

    improvement in NYHA class

    3 months

Secondary Outcomes (3)

  • Maximal oxygen consumption (VO2)

    6 months

  • natriuretic peptide levels

    3 months

  • left ventricular size

    6 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Advanced symptomatic heart failure patients with reduced ejection fraction in whom a left ventricular assist device implantation is planned.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Central Study Contacts

Ofer Havakuk, MD

CONTACT

+97236974250oferh@tlvmc.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2022

First Posted

March 8, 2022

Study Start

January 1, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations

IL(1)