Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation

NCT ID: NCT02387112

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2024-12-31

Brief Summary

The aim of the study is to assess whether, in patients who are listed for cardiac transplantation in transplantable (T) status, early implantation of a left ventricular assist device is superior to the current therapeutic strategy of medical heart failure therapy and assist device implantation only after serious deterioration of the patient's condition.

Detailed Description

Heart transplantation is considered the gold-standard therapy for end-stage systolic heart failure but the shortage of donor hearts in Germany and other countries has led to widespread use of left ventricular assist devices (LVAD). Even on the transplant list, patients' condition often deteriorate due to worsening heart failure so that they need an LVAD as a bridge until transplantation. The high mortality (one in five patients on the waiting list dies within 1 year) reflects the severity of the disease. In comparison, technical progress has reduced the complication rate seen with assist devices and, according to recent data, mortality during LVAD support is low. Patient status prior to LVAD implantation is a strong indicator for postoperative outcome, i.e. patients in worse condition are more likely to develop complications. Thus, the comparison between the standard indication and early LVAD implantation (T-status) appears timely and clinically necessary.

The paucity of donor hearts necessitates the prospective evaluation of alternative treatment regimens. The aim of the study is to assess whether, in patients with end-stage heart failure awaiting cardiac transplantation, a strategy involving early LVAD implantation is superior to a strategy of conservative medical heart failure therapy and assist device implantation only after severe deterioration of heart failure.

The investigators expect to gain insights that will be trail-blazing for the future treatment of patients with heart failure on the transplantation waiting list, including aspects of their medical care. If the study hypotheses are confirmed, the treatment of these seriously ill patients could be, on the one hand, further optimized. On the other hand, positive economic effects are highly probable.

The results will form the basis of future guidelines for the treatment of this group of patients.

Thus the study will also make a contribution to solving the problem of the ever increasing number of patients on the waiting list as opposed to the decreasing willingness to donate organs for transplantation.

As a mean of quality control of the conducted study and to retrieve more data in this population all patients who fulfill the eligibility criteria of the study but do not consent to randomization are included in a standard treatment registry.

Conditions

End Stage Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early VAD implantation

The experimental intervention is early implantation of a left ventricular assist device (early VAD). Patients randomized to early VAD implantation will obtain a VAD within 28 days after randomization.

Group Type: EXPERIMENTAL

Early VAD implantation

Intervention Type: DEVICE

Implantation of a left ventricular assist device

Emergency VAD implantation

The control intervention is conservative heart failure treatment, with LVAD implantation in the case of worsening heart failure (emergency VAD). All patients randomized to the control intervention will be treated according to standard medical practice. In brief, these patients are closely monitored (scheduled regular visits to outpatient department depending on the patient's condition and at least every 6 months). If the condition worsens the patient may qualify for high urgency (HU) listing and/or for VAD implantation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early VAD implantation

Implantation of a left ventricular assist device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient (male or female) eligible for heart transplantation and accepted in T Status (transplantable) on the waiting list
• Age 18 to 65 years
• Signed informed consent
• >30% 1-year mortality with the Seattle Heart Failure Model (SHFM) or at least three of the following criteria (a) to (f):

1. cardiac index (CI) <2.5 l/min/m²

2. pulmonary capillary wedge pressure >15 mmHg

3. maximal oxygen uptake (VO2max) ≤10.0 ml/kg/min or ≤12.0 ml/kg/min in patients intolerant of a ß-blocker

4. ratio of minute ventilation (VE) to carbon dioxide (VCO2) production (VE/VCO2) slope of >35

5. at least two hospitalizations for heart failure within the previous 12 months

6. documented increase of brain natriuretic peptide (BNP) or NTproBNP levels despite optimal medical therapy

Exclusion Criteria

• Listing for transplantation of other organs in addition to heart
• Previous cardiac surgeries (other than pacemaker or ICD surgeries)
• Contraindications to assist device implantation (e.g. mechanical aortic valve, aortic insufficiency)
• Contraindications to anticoagulation
• Expected need for a right ventricular assist device/biventricular support expected (e.g. due to tricuspid valve insufficiency grade 3+, right ventricular ratio short/long axis ≥0.6, ratio of right to left ventricular end-diastolic diameter (RVEDD/LVEDD) >0.72, restrictive cardiomyopathy)
• Presence of catecholamine support or intra-aortic balloon counterpulsation (IABP)
• Overt infections
• Fixed pulmonary hypertension (i.e. pulmonary arterial pressure (PAP) >60 mmHg and mean transpulmonary gradient (TPG) >15 mmHg or pulmonary vascular resistance (PVR) >6 Wood units despite optimal medical treatment)
• Renal insufficiency (glomerular filtration rate (GFR) <30ml/min or need for hemodialysis or hemofiltration)
• Significant coagulopathies
• Systemic lupus erythematosus, sarcoid, or amyloidosis that has multisystem involvement and is still active
• Drug abuse and/or alcohol abuse
• Incompliance
• Elevated panel reactivity levels of >50 %
• Pregnancy or breast feeding in women
• Participation in other investigational trials

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

Helmholtz Zentrum München

INDUSTRY

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: collaborator

University of Göttingen

OTHER

Sponsor Role: collaborator

German Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volkmar Falk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

German Heart Institute Berlin Germany

Locations

Universitäts-Herzzentrum Freiburg Bad Krozingen - Klinik für Herz- und Gefäßchirurgie

Bad Krozingen, , Germany

Kerckhoff Klinik Bad Nauheim

Bad Nauheim, , Germany

Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum

Bad Oeynhausen, , Germany

Charité - Universitätsmedizin Berlin: Campus Benjamin Franklin

Berlin, , Germany

German Heart Center Berlin

Berlin, , Germany

Universitätsklinikum Erlangen - Herzchirurgische Klinik

Erlangen, , Germany

Universitätsklinikum Frankfurt - Klinik für Thorax-, Herz- und thorakale Gefäßchirurgie

Frankurt Am Main, , Germany

Universitätsmedizin Göttingen

Göttingen, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Med. Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie

Hanover, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Jena, Klinik für Herz- und Thoraxchirurgie

Jena, , Germany

Universitätsklinikum Schleswig Holstein - Campus Kiel

Kiel, , Germany

Heart Center Leipzig

Leipzig, , Germany

Universitätsklinik für Herz- und Thoraxchirurgie

Magdeburg, , Germany

Universitätsklinikum Gießen und Marburg Klinik für Herz- und thorakale Gefäßchirurgie

Marburg, , Germany

Herzchirurgische Klinik und Poliklinik des Klinikums der Universität München - Campus Großhadern

München, , Germany

Universitätskrankenhaus Münster

Münster, , Germany

Countries

Germany

Other Identifiers

VAD Study Germany

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DZHK VAD Study

Identifier Type: -

Identifier Source: org_study_id