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.
The primary aims of the registry will be: * To examine the safety, efficacy, and long-term outcomes of TTVR * To assess the incidence of procedural complications and their correlations with adverse clinical outcomes * To investigate the impact of different pre/post-procedural factors on peri-procedural complications and long-term outcomes after TTVR * To explore the characteristics of patients deemed eligible for TTVR.
Study Type
OBSERVATIONAL
Enrollment
800
All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease
Arizona Heart Hospital (Biltmore Cardiology)
Phoenix, Arizona, United States
RECRUITINGColumbia University Irving Medical Center
New York, New York, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGOregon Health & Science University
Portland, Oregon, United States
ENROLLING_BY_INVITATIONSt. Paul's Hospital
Vancouver, British Columbia, Canada
RECRUITINGSt Michael's Hospital, University of Toronto
Toronto, Ontario, Canada
RECRUITINGQuebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
Québec, Quebec, Canada
RECRUITINGRigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
RECRUITINGChu De Bordeaux - Haut-Lévêque Hospital
Bordeaux, Pessac, France
RECRUITING...and 11 more locations
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 procedure
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 procedure
Permanent Pacemaker Implantation
The number of participants who have received a permanent pacemaker implantation will be recorded
Time frame: 30 days after the index procedure
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 procedure
All-cause mortality
The number of deaths due to any cause will be recorded
Time frame: 12 months after the index procedure
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 procedure
The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure
The number of participants who meet either NYHA III or NYHA IV classifications for heart failure will be recorded. NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients
Time frame: 12 months after the index procedure
Device Thrombosis
The number of participants who have been identified with device thrombosis will be recorded
Time frame: 12 months after the index procedure
Tricuspid Regurgitation Severity
Tricuspid Regurgitation is measured by transthoracic echocardiography. Assessment of MI severity will be conducted 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. Higher mean scores are indicative of greater TR severity
Time frame: 12 months after the index procedure
Quality of Life - Kansas City Cardiomyopathy Questionnaire
Quality of Life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ has a 2-week recall period and includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score that mirrors the key concepts of the NYHA functional class. The symptom, physical limitations, social limitations, and quality of life domains are combined to create an overall summary score, which is the primary health status outcome All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life
Time frame: 12 months after the index procedure
Tricuspid Valve Reintervention
The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded
Time frame: 12 months after the index procedure
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