International Multisite Transcatheter Tricuspid Valve Therapies Registry

NCT ID: NCT03416166

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 269 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2026-11-01

Brief Summary

For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1).

Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied.

The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.

Conditions

Severe Tricuspid Regurgitation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Transcatheter Tricuspid Intervention

Any available transcatheter tricuspid valve intervention

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All the patients undergoing transcatheter tricuspid valve intervention.

• Minimal age: 18 years
• Patient is able to give written informed consent to the procedure

Exclusion Criteria

• Patients not fulfilling the indications for transcatheter tricuspid intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Zurich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Maurizio Taramasso, MD, PhD

Role: CONTACT

maurizio.taramasso@usz.ch

0041442553728

Facility Contacts

Maurizio Taramasso, MD, PhD

Role: primary

maurizio.taramasso@usz.ch

0041442553728

References

Scotti A, Coisne A, Taramasso M, Granada JF, Ludwig S, Rodes-Cabau J, Lurz P, Hausleiter J, Fam N, Kodali SK, Rosiene J, Feinberg A, Pozzoli A, Alessandrini H, Biasco L, Brochet E, Denti P, Estevez-Loureiro R, Frerker C, Ho EC, Monivas V, Nickenig G, Praz F, Puri R, Sievert H, Tang GHL, Andreas M, Von Bardeleben RS, Rommel KP, Muntane-Carol G, Gavazzoni M, Braun D, Koell B, Kalbacher D, Connelly KA, Juliard JM, Harr C, Pedrazzini G, Russo G, Philippon F, Schofer J, Thiele H, Unterhuber M, Himbert D, Alcazar MU, Wild MG, Windecker S, Jorde U, Maisano F, Leon MB, Hahn RT, Latib A. Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation. Eur Heart J. 2023 Mar 7;44(10):822-832. doi: 10.1093/eurheartj/ehac735.

Reference Type: DERIVED

PMID: 36445158 (View on PubMed)

Muntane-Carol G, Taramasso M, Miura M, Gavazzoni M, Pozzoli A, Alessandrini H, Latib A, Attinger-Toller A, Biasco L, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Lubos E, Ludwig S, Kalbacher D, Estevez-Loureiro R, Fam N, Frerker C, Ho E, Juliard JM, Kaple R, Kodali S, Kreidel F, Harr C, Lauten A, Lurz J, Monivas V, Mehr M, Nazif T, Nickening G, Pedrazzini G, Philippon F, Praz F, Puri R, Schafer U, Schofer J, Sievert H, Tang GHL, Khattab AA, Andreas M, Russo M, Thiele H, Unterhuber M, Himbert D, Urena M, von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Hausleiter J, Lurz P, Maisano F, Leon MB, Hahn RT, Rodes-Cabau J. Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry. Circ Cardiovasc Interv. 2021 Feb;14(2):e009685. doi: 10.1161/CIRCINTERVENTIONS.120.009685. Epub 2021 Feb 5.

Reference Type: DERIVED

PMID: 33541097 (View on PubMed)

Miura M, Alessandrini H, Alkhodair A, Attinger-Toller A, Biasco L, Lurz P, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Estevez-Loureiro R, Fam N, Frerker C, Gavazzoni M, Hausleiter J, Himbert D, Ho E, Juliard JM, Kaple R, Besler C, Kodali S, Kreidel F, Kuck KH, Latib A, Lauten A, Monivas V, Mehr M, Muntane-Carol G, Nazif T, Nickenig G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodes-Cabau J, Schafer U, Schofer J, Sievert H, Tang GHL, Thiele H, Rommel KP, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Maisano F, Hahn RT, Taramasso M; TriValve Investigators. Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1999-2009. doi: 10.1016/j.jcin.2020.05.011.

Reference Type: DERIVED

PMID: 32912460 (View on PubMed)

Other Identifiers

2016-01753

Identifier Type: -

Identifier Source: org_study_id