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AzTrials

Severe Tricuspid RegurgitationTriValveNCT03416166

International Multisite Transcatheter Tricuspid Valve Therapies Registry

An observational study of Severe Tricuspid Regurgitation, run by University of Zurich at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Severe Tricuspid Regurgitation
What is being tested?
Transcatheter Tricuspid Intervention
Type of treatment
Medical device
How many people
269 participants
Where
1 siteSwitzerland
Study dates
1 Nov 2016to 1 Nov 2026
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Adult, Older adult

Study population: Patients with severe symptomatic tricuspid regurgitation

Who may be able to join

  • All the patients undergoing transcatheter tricuspid valve intervention.
  • General inclusion criteria:
  • Minimal age: 18 years
  • Patient is able to give written informed consent to the procedure

Who cannot join

  • Patients not fulfilling the indications for transcatheter tricuspid intervention

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maurizio Taramasso, MD, PhD contact

0041442553728

maurizio.taramasso@usz.ch

Switzerland1 site, 1 recruiting

  • University Hospital Zurich

    Zurich

    Maurizio Taramasso, MD, PhD, 0041442553728, maurizio.taramasso@usz.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Being tested
Transcatheter Tricuspid Intervention
Keywords
Tricuspid Valve, tricuspid regurgitation, transcatheter tricuspid regurgitation
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter Tricuspid InterventionDevice

    Any available transcatheter tricuspid valve intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular Death

    Measured: 30 days

Secondary outcomes (2)

  1. NYHA Class

    Measured: 30 days, 1 year

  2. TR Reduction

    Measured: 30 days, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start1 Nov 2016
  3. Primary completion15 May 2017
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
269 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03416166
Sponsor's protocol ID
2016-01753
Other IDs
2016
Acronym
TriValve
Status last verified
Jan 2018
First submitted
23 Jan 2018
Last updated
30 Jan 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Russo G, Pedicino D, Pires Marafon D, Adamo M, Alessandrini H, Andreas M, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Hahn RT, Harr C, Hausleiter J, Himbert D, Kalbacher D, Ho E, Latib A, Lentini N, Lubos E, Ludwig S, Lurz P, Metra M, Monivas V, Nickenig G, Pastorino R, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Besler C, Rommel KP, Schofer J, Scotti A, Piayda K, Sievert H, Tang GHL, Thiele H, Schlotter F, von Bardeleben RS, Webb JG, Windecker S, Leon M, Enriquez-Sarano M, Maisano F, Crea F, Taramasso M. TRIVALVE Score: A Risk Score for Mortality/Hospitalization Prediction in Patients Undergoing Transcatheter Tricuspid Valve Intervention. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2170-2179. doi: 10.1016/j.jcin.2024.08.009.

    PubMed 39322365

  • Russo G, Hahn RT, Alessandrini H, Andreas M, Badano LP, Braun D, Connelly KA, Denti P, Estevez-Loureiro R, Fam N, Gavazzoni M, Hausleiter J, Himbert D, Kalbacher D, Latib A, Lubos E, Ludwig S, Lurz P, Monivas V, Nickenig G, Pedicino D, Pedrazzini G, Pozzoli A, Praz F, Rodes-Cabau J, Rommel KP, Schofer J, Sievert H, Tang G, Thiele H, Unterhuber M, von Bardeleben RS, Webb J, Windecker S, Leon M, Maisano F, Taramasso M. Effects of tricuspid transcatheter edge-to-edge repair on tricuspid annulus diameter - Data from the TriValve registry. Int J Cardiol. 2024 Jun 15;405:131934. doi: 10.1016/j.ijcard.2024.131934. Epub 2024 Mar 2.

    PubMed 38437953

  • 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.

    PubMed 36445158

  • 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.

    PubMed 33541097

  • 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.

    PubMed 32912460

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Tricuspid Regurgitation, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maurizio Taramasso, MD, PhD (0041442553728, maurizio.taramasso@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular Death (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03416166, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.

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