Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Serious adverse device effects |
Incidence of any serious adverse device effects. |
1 year |
|
Other |
Adverse device effects |
Incidence of any adverse device effects |
1 year |
|
Other |
Device dysfunction resulting in loss of transplantable heart |
Number of transplantable hearts lost due to device dysfunction |
12 hours |
|
Other |
Intra operative details; duration of ECC |
Duration of ECC in minutes |
12 hours |
|
Other |
Intra operative details; duration of cross clamp |
Duration of cross clamp in minutes |
12 hours |
|
Other |
Intra operative details; duration of surgery |
Duration of surgery in minutes |
12 hours |
|
Other |
Intra operative details; attempts to wean off ECC |
Number of attempts to wean off ECC |
12 hours |
|
Other |
Intra operative details; need for inotropic support |
Need for inotropic support (inotropic score) |
12 hours |
|
Other |
Intra operative details; need for pulmonary vasodilator |
Need for pulmonary vasodilator |
12 hours |
|
Other |
Intra operative details; defibrillations |
Number of defibrillations |
12 hours |
|
Other |
Intra operative details; arryhythmias |
Occurence of arryhythmias |
12 hours |
|
Other |
Intra operative details; conduction abnormalities |
Number of conduction abnormalities |
12 hours |
|
Other |
Intra operative details; Left ventricular ejection fraction (LVEF) |
LVEF in percentage |
12 hours |
|
Other |
Intra operative details; Right ventricular ejection fraction (RVEF) |
RVEF in percentage |
12 hours |
|
Other |
Intra operative details; Mitral valve regurgitations |
Grade of mitral valve regurgitations |
12 hours |
|
Other |
Intra operative details; Tricuspid valve regurgitations |
Occurence of tricuspid vavle regurgitations |
12 hours |
|
Other |
Arterial blood gas lactate |
Arterial blood gas lactate at 6 hours |
6 hours |
|
Other |
Arterial blood gas lactate |
Arterial blood gas lactate at 24 hours |
24 hours |
|
Other |
Pro-BNP during follow up |
Pro-BNP at predefined time points during follow-up. |
1 year |
|
Primary |
30 days mortality and 30 days graft dysfunction |
The Primary End-Point is defined as time-to-first-event of cardiac related death, moderate or severe primary graft dysfunction of the left ventricle or primary graft dysfunction of the right ventricle (according to Kobashigawa et al., 2014), acute cellular rejection =2R (according to Stewart et al., 2005) or graft failure (use of mechanical circulatory support or retransplantation) within 30 days. |
30 days |
|
Secondary |
1 year mortality and 1 year graft dysfunction |
The key secondary endpoint is defined as time-to-first-event of either any cause of death, moderate or severe PGD-LV or PGD-RV (according to Kobashigawa et al., 2014), acute cellular rejection =2R (according to Stewart et al., 2005) or graft failure (use of mechanical circulatory support or retransplantation) or CAV = 1 (according to Mehra, 2010) within 12 months. |
1 year |
|
Secondary |
30 days and 1 year mortality and graft dysfunction |
The individual variables included in the composite primary endpoint at 30 days and 1 year analyzed as time-to-first-event. |
30 days and 1 year |
|
Secondary |
CKMB |
Creatine kinase MB (CKMB) at 6 ±2 h, 24 ±6 h, 48±6 h and 72±6 h after cross clamp removal |
3 days |
|
Secondary |
TnI |
Tropinin I (TnI) at 6 ±2 h, 24 ±6 h, 48±6 h and 72±6 h after cross clamp removal |
3 days |
|
Secondary |
ProBNP |
Pro Brain Natriuretic Protein (ProBNP) at 6 ±2 h, 24 ±6 h, 48±6 h and 72±6 h after cross clamp removal |
3 days |
|
Secondary |
Stay in ICU |
Length of Stay at Intensive Care Unit, reported as number of days |
1 year |
|
Secondary |
Cardiac Transplant Events |
Incidence of Major Adverse Cardiac Transplant Events |
1 year |
|
Secondary |
Postoperative use of mechanical circulatory support |
Incidence of use of postoperative mechanical circulatory support, reported as number of days |
1 year |
|
Secondary |
Postoperative duration of mechanical circulatory support |
Duration of use of postoperative mechanical circulatory support, reported as number of days |
1 year |
|
Secondary |
Overall success/failure 30 days |
Success is defined as a recipient that are transplanted and alive at 30 days without any of the complication in the primary endpoint before 30 days. |
30 days |
|
Secondary |
Overall success/failure 1 year |
Success is defined as a recipient that are transplanted and alive at 1 year without any of the complication given in key secondary endpoint before 1 year. |
1 year |
|
Secondary |
ECHO data (Left ventricular ejection fraction) |
ECHO data with Left ventricular ejection fraction in percentage within 24 hours after transplantation |
24 hours |
|
Secondary |
ECHO data (Left ventricular ejection fraction) |
ECHO data with Left ventricular ejection fraction in percentage 1 week after transplantation |
1 week |
|
Secondary |
ECHO data (Left ventricular ejection fraction) |
ECHO data with Left ventricular ejection fraction in percentage 6 months after transplantation |
6 months |
|
Secondary |
ECHO data (Left ventricular ejection fraction) |
ECHO data with Left ventricular ejection fraction in percentage 1 year after transplantation |
1 year |
|
Secondary |
ECHO data (Right ventricular ejection fraction) |
ECHO data with Right ventricular ejection fraction in percentage within 24 hours after transplantation |
24 hours |
|
Secondary |
ECHO data (Right ventricular ejection fraction) |
ECHO data with Right ventricular ejection fraction in percentage 1 week after transplantation |
1 week |
|
Secondary |
ECHO data (Right ventricular ejection fraction) |
ECHO data with Right ventricular ejection fraction in percentage 6 months after transplantation |
6 months |
|
Secondary |
ECHO data (Right ventricular ejection fraction) |
ECHO data with Right ventricular ejection fraction in percentage 1 year after transplantation |
1 year |
|
Secondary |
ECHO data (Tricuspid annular plane systolic excursion) |
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm within 24 hours after transplantation |
24 hours |
|
Secondary |
ECHO data (Tricuspid annular plane systolic excursion) |
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm 1 week after transplantation |
1 week |
|
Secondary |
ECHO data (Tricuspid annular plane systolic excursion) |
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm 6 months after transplantation |
6 months |
|
Secondary |
ECHO data (Tricuspid annular plane systolic excursion) |
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm 1 year after transplantation |
1 year |
|