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

NCT02387112 | Unknown DMC

• 2 other identifiers: DZHK VAD StudyVAD Study Germany
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 18

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.

Conditions

End Stage Heart Disease

Keywords

End stage heart disease; Ventricular assist device

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  The time to the composite end-point of all-cause death, high urgent cardiac transplantation, disabling stroke , HF hospitalizations (including emergency room HF visits \>6 hrs).

  Randomisation untill month 60 (60 months at the most, 48 months on average)

Secondary Outcomes (21)

• Stroke

  Randomisation untill month 60 (60 months at the most, 48 months on average)

• Listing for high-urgency (HU) cardiac transplantation

  Randomisation untill month 60 (60 months at the most, 48 months on average)

• Number of patients with de novo right heart failure measured by decreasing right heart ejection fraction, increasing central venous pressure and/or secondary organ failure needing catecholamines and/or right ventricular circulatory support

  Randomisation untill month 60 (60 months at the most, 48 months on average)

• Number of patients with hospitalizations due to device failure

  Randomisation untill month 60 (60 months at the most, 48 months on average)

• Number of patients with adverse events due to device failure

  Randomisation untill month 60 (60 months at the most, 48 months on average)

Study Arms (2)

Early VAD implantation

EXPERIMENTAL

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.

Device: Early VAD implantation

Emergency VAD implantation

NO INTERVENTION

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.

Interventions

Early VAD implantation DEVICE

Implantation of a left ventricular assist device

Early VAD implantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• cardiac index (CI) \<2.5 l/min/m²
• pulmonary capillary wedge pressure \>15 mmHg
• maximal oxygen uptake (VO2max) ≤10.0 ml/kg/min or ≤12.0 ml/kg/min in patients intolerant of a ß-blocker
• ratio of minute ventilation (VE) to carbon dioxide (VCO2) production (VE/VCO2) slope of \>35
• at least two hospitalizations for heart failure within the previous 12 months
• documented increase of brain natriuretic peptide (BNP) or NTproBNP levels despite optimal medical therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• German Heart Institute: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator
• Helmholtz Zentrum München: collaborator
• University Medicine Greifswald: collaborator
• University of Göttingen: collaborator

Study Sites (18)

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

Bad Krozingen, 79189, Germany

Location

Kerckhoff Klinik Bad Nauheim

Bad Nauheim, 61231, Germany

Location

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

Bad Oeynhausen, 32545, Germany

Location

Charité - Universitätsmedizin Berlin: Campus Benjamin Franklin

Berlin, 12203, Germany

Location

German Heart Center Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Erlangen - Herzchirurgische Klinik

Erlangen, 91054, Germany

Location

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

Frankurt Am Main, 60590, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

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

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Jena, Klinik für Herz- und Thoraxchirurgie

Jena, 07747, Germany

Location

Universitätsklinikum Schleswig Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Heart Center Leipzig

Leipzig, 04289, Germany

Location

Universitätsklinik für Herz- und Thoraxchirurgie

Magdeburg, 39120, Germany

Location

Universitätsklinikum Gießen und Marburg Klinik für Herz- und thorakale Gefäßchirurgie

Marburg, 35043, Germany

Location

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

München, 81377, Germany

Location

Universitätskrankenhaus Münster

Münster, 48149, Germany

Location

Study Officials

• Volkmar Falk, MD, PhD

  German Heart Institute Berlin Germany

  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

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: March 12, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

DE (18)