Tricuspid Valve RegurgitationbRIGHTNCT04483089
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)
An observational study of Tricuspid Valve Regurgitation, run by Abbott Medical Devices at 25 sites in 8 countries.
Trial summary
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation
- What is being tested?
- Transcatheter heart valve procedure
- Type of treatment
- Medical device
- How many people
- 511 participants
- Where
- 25 sitesin 8 countries
- Study dates
- 27 Aug 2020to Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™ per the current approved Indications For Use.
Who may be able to join
- Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
- Subject must provide written informed consent prior to study procedure.
Who cannot join
- 1. Subjects participating in another clinical study that may impact the follow-up or results of this study.
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
Germany14 sites
Zentralklinik Bad Berka GmbH
Bad Berka
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
Bad Rothenfelde
DRK Kliniken Köpenick
Berlin
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
St.-Johannes-Hospital
Dortmund
Elisabeth-Krankenhaus Essen GmbH
Essen
Katholisches Marienkrankenhaus GmbH
Hamburg
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg
Leipzig Heart Center
Leipzig, Saxony, 04289
Otto-von-Guericke-Universität Magdeburg
Magdeburg
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, 55131
Robert-Bosch-Krankenhaus
Stuttgart
Universitätsklinikum Ulm
Ulm
Spain3 sites
Hospital de Sant Pau
Barcelona, Barcelona, 08025
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital Álvaro Cunqueiro
Vigo
Switzerland2 sites
Inselspital Bern
Bern, 3010
HerzKlinik Hirslanden - Klinik Hirslanden
Zurich, Canton of Zurich, 8032
About this study
Official title: An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
Read the detailed description
The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.
- Conditions
- Tricuspid Valve Regurgitation
- Being tested
- Transcatheter heart valve procedure
- 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 heart valve procedureDevice
Transcatheter treatment of TR with Abbott TriClip™.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success (APS)
The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure.
Measured: up to 30 days
Secondary outcomes (1)
Composite endpoint of all-cause mortality or TR re-intervention
The secondary endpoint is a composite endpoint of all-cause mortality or tricuspid valve re-intervention/re-operation at 1 year.
Measured: at 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start27 Aug 2020
- Primary completion31 Dec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meghan Griffin, Study director, Clinical Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483089
- Sponsor's protocol ID
- ABT-CIP-10317
- Acronym
- bRIGHT
- Status last verified
- Jan 2026
- First submitted
- 16 Jul 2020
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lurz P, Rommel KP, Schmitz T, Bekeredjian R, Nickenig G, Mollmann H, von Bardeleben RS, Schmeisser A, Atmowihardjo I, Estevez-Loureiro R, Lubos E, Heitkemper M, Peterman K, Lapp H, Donal E. Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study. J Am Coll Cardiol. 2024 Aug 13;84(7):607-616. doi: 10.1016/j.jacc.2024.05.006. Epub 2024 May 15.
PubMed 38759905Lurz P, Besler C, Schmitz T, Bekeredjian R, Nickenig G, Mollmann H, von Bardeleben RS, Schmeisser A, Atmowihardjo I, Estevez-Loureiro R, Lubos E, Heitkemper M, Huang D, Lapp H, Donal E; bRIGHT PAS Principal Investigators. Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice. J Am Coll Cardiol. 2023 Jul 25;82(4):281-291. doi: 10.1016/j.jacc.2023.05.008. Epub 2023 May 17.
PubMed 37207923
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device
- ClinicalTrials.gov ID
- NCT04483089
- Acronym / sponsor ID
- bRIGHT / ABT-CIP-10317
- Conditions
- Tricuspid Valve Regurgitation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
Detailed description
The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™ per the current approved Indications For Use.
Key inclusion criteria (3 listed)
- Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
- Subject must provide written informed consent prior to study procedure.
Key exclusion criteria (1 listed)
- 1. Subjects participating in another clinical study that may impact the follow-up or results of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter heart valve procedureTranscatheter treatment of TR with Abbott TriClip™. | Device | – |
Primary outcome
Acute Procedural Success (APS)
Time frame: up to 30 days
The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure.
1 secondary outcome
Composite endpoint of all-cause mortality or TR re-intervention
Time frame: at 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 38759905Lurz P, Rommel KP, Schmitz T, Bekeredjian R, Nickenig G, Mollmann H, von Bardeleben RS, Schmeisser A, Atmowihardjo I, Estevez-Loureiro R, Lubos E, Heitkemper M, Peterman K, Lapp H, Donal E. Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study. J Am Coll Cardiol. 2024 Aug 13;84(7):607-616. doi: 10.1016/j.jacc.2024.05.006. Epub 2024 May 15.
- Derived from this study: PubMed 37207923Lurz P, Besler C, Schmitz T, Bekeredjian R, Nickenig G, Mollmann H, von Bardeleben RS, Schmeisser A, Atmowihardjo I, Estevez-Loureiro R, Lubos E, Heitkemper M, Huang D, Lapp H, Donal E; bRIGHT PAS Principal Investigators. Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice. J Am Coll Cardiol. 2023 Jul 25;82(4):281-291. doi: 10.1016/j.jacc.2023.05.008. Epub 2023 May 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Griffin study director
Clinical Program Director
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Valve Regurgitation, run by Abbott Medical Devices at 25 sites in 8 countries.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Spain, Italy, Switzerland, Austria and 3 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Procedural Success (APS) (time frame: up to 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 NCT04483089, which also lists 2 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 18 May 2026.