Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing Transcatheter Tricuspid Valve Replacement
Native Tricuspid Valve disease
Orthotopic Tricuspid Valve Implantation
Disqualifiers
Age under 18 years
Trial population
Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Transcatheter Tricuspid Valve Replacement
DeviceAll patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement1 intervention
Trial outcomes
Primary outcomes
1
Freedom from device-related complications
Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications
Time frame
30 days after the index procedure2
Reduction in Tricuspid Regurgitation Severity
Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed
Time frame
30 days after the index procedureSecondary outcomes
1
Permanent Pacemaker Implantation
The number of participants who have received a permanent pacemaker implantation will be recorded
Time frame
30 days after the index procedure2
Combined all-cause mortality or rehospitalization for congestive heart failure
The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded
Time frame
12 months after the index procedure3
All-cause mortality
The number of deaths due to any cause will be recorded
Time frame
12 months after the index procedure4
Hospitalization for congestive heart failure
The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded
Time frame
12 months after the index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
The Cleveland Clinic
Collaborator
University of Toronto
Collaborator
University Hospital, Bordeaux
Collaborator
Source ClinicalTrials.gov