TARGET-LOAD Pilot Study Comparing Hemodynamics-guided LVAD Unloading Vs. Standard of Care

NCT04977310 | Withdrawn DMC FDA Device

• 1 other identifier: IRB_00143654
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a prospective, randomized-controlled, non-blinded, multi-center, pilot trial to compare standard-of-care left ventricular assist device (LVAD) unloading plus heart failure (HF) medications reverse-remodeling management versus hemodynamics-guided LVAD unloading with use of the wireless monitoring system CardioMEMS plus HF medications reverse-remodeling management.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects that meet explantation criteria by month 12 post-LVAD implantation, have LVAD explanted and retain left ventricular ejection fraction >=45% at 12 months post-LVAD weaning

  Removal of LVAD happens when subject meets all five of the following explantation criteria: (1) left ventricular end-diastolic diameter \< 60mm; (2) left ventricular end-systolic diameter \< 50mm; (3) left ventricular ejection fraction \> 45%; (4) left ventricular end-diastolic pressure \<= 15 mmHg; (5) resting cardiac index \> 2.4 L/min/m\^2

  24 months

Secondary Outcomes (2)

• Hospital Admissions

  24 months

• Six-minute Walk Test

  12 months

Study Arms (2)

Control

NO INTERVENTION

After LVAD implantation, patients undergo cardiac rehab and pump speed will be optimized to maximize left ventricular unloading using echocardiographic imaging and other standard-of-care practices. During the Unloading phase, patients are serially evaluated with echocardiograms to assess for cardiac recovery, and LVAD explantation performed when predefined criteria are met. After explantation, patients undergo cardiac rehab and regular follow up.

Intervention

EXPERIMENTAL

After LVAD and wireless monitoring system (CardioMEMS) implantation, patients undergo cardiac rehab and pump speed will be optimized to maximize left ventricular unloading using CardioMEMS. During the Unloading phase, invasive hemodynamic guidance (via CardioMEMS) will be utilized to optimize pressure and volume unloading along with serial echocardiographic evaluations to assess for cardiac recovery, and LVAD explantation will be considered. After explantation, patients will undergo cardiac rehab and regular follow up with adjustments of HF medications based on the CardioMEMS-guided hemodynamic assessment.

Device: CardioMEMS

Interventions

CardioMEMS DEVICE

Cardio-MEMS-guided Post-LVAD cardiac unloading and recovery

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Severe clinical HF resistant to intensive medical therapy and requiring LVAD implantation
• Left ventricular ejection fraction \<=25% and cardiomegaly at time of LVAD implantation
• Non-ischemic etiology of HF
• Undergone LVAD implantation within prior 4 weeks or planned for LVAD implant
• History of HF \< 5 years
• Body Mass Index \<=35 kg/m\^2
• Pulmonary artery branch diameter between 7 - 15 mm
• Female subjects of childbearing age with negative urine or serum pregnancy test and agreeing to use reliable mechanical or hormonal form of contraception during study

You may not qualify if:

• Evidence of active acute myocarditis confirmed by histology
• History of previous cerebrovascular accident resulting in significant fixed motor deficit, limiting ability to perform exercise testing
• Implanted mechanical aortic and/or mitral valve(s) and/or right heart valve(s)
• Aortic valve closure
• Hypertrophic obstructive cardiomyopathy or sarcoidosis
• Left ventricular end-diastolic diameter below normal (restrictive cardiomyopathy)
• Irreversible multi-organ failure
• Diagnosis of psychiatric disease, irreversible cognitive dysfunction or poor psycho-social issues likely to impair compliance with study protocol
• Any condition that could limit survival to less than 2 years
• History of cardiac or other organ transplant
• Contraindicated to anti-coagulation, antiplatelet therapy, or diagnosis of coagulation disorders
• Require acute or chronic renal replacement therapy within 3 months prior to enrollment
• Participation in any other clinical investigations involving another Mechanical Circulating Support device or HF-related drug
• Active infection
• History of recurrent (\>1) pulmonary embolism or deep vein thrombosis

Sponsors & Collaborators

• STAVROS G DRAKOS: lead
• Abbott: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stavros Drakos, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Cardiovascular Medicine

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)