MELODY Registry Follow-Up Study
ConditionCongenital Heart Disease (CHD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital Tuebingen
About this trial
Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
previous inclusion in the MELODY Registry
Disqualifiers
none
Trial population
Patients who underwent Melody valve implantation into the pulmonary position after its commercialization in Europe / OUS
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
primary outcome
• composite endpoint of TPVI related follow-up events (i.e. death, reoperation, or reintervention \>48h after TPVI)
Time frame
from december 2006 up to December 2027Secondary outcomes
1
secondary measure
TPVI infective endocarditis (I.E.) according to modified Duke criteria n
Time frame
from december 2006 up to December 2027Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov