Tricuspid RegurgitationPASTENCT05328284
PASCAL for Tricuspid Regurgitation - a European Registry
An observational study of Tricuspid Regurgitation, run by LMU Klinikum at 14 sites in 3 countries.
Trial summary
This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in an observational fashion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- PASCAL leaflet repair system
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 5 May 2021to 30 May 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 consecutive patients that have undergone transcatheter tricuspid valve repair with the PASCAL system since its commercial approval in 02/2019 at the participating centres shall be included in the study.
Who may be able to join
- Patients treated with the PASCAL system for tricuspid regurgitation in a commercial setting
Who cannot join
- Patient age < 18 years
Trial locations and contacts
14 sites in 3 countries.
Mirjam Wild, MD contact
14 sites in 3 countries
Germany11 sites, 11 recruiting
- Recruiting
Zentralklinik Bad Berka GmbH
Bad Berka
Harald Lapp, MD, Harald.Lapp@zentralklinik.de
- Recruiting
Herz & Diabeteszentrum Nordrhein Westfalen
Bad Oeynhausen
Volker Rudolph, MD, vrudolph@hdz-nrw.de
- Recruiting
Universitätsklinikum Essen
Essen
Peter Lüdike, MD, Peter.Luedike@uk-essen.de
- Recruiting
Marienkrankenhaus Hamburg
Hamburg
Edith Lubos, e.lubos@marienkrankenhaus.org
- Recruiting
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg
Niklas Schofer, MD, n.schofer@uke.de
- Not yet recruiting
Universitätsklinikum Heidelberg
Heidelberg
Mathias Konstandin, Mathias.Konstandin@med.uni-heidelberg.de
- Recruiting
Herzzentrum Leipzig
Leipzig
Philipp Lurz, MD, Philipp.Lurz@medizin.uni-leipzig.de
- Recruiting
LMU University Hospital
Munich
Jörg Hausleiter, MD, joerg.hausleiter@med.uni-muenchen.de
- Recruiting
Universitätsklinikum Siegburg
Siegburg
Peter Boekstegers, MD
- Recruiting
Universitätsklinikum Tübingen
Tübingen
Tobias Geisler, Tobias.Geisler@med.uni-tuebingen.de
- Recruiting
Universitätsklinik Ulm
Ulm
Mirjam Kessler, MD, mirjam.kessler@uniklinik-ulm.de
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital Bern
Bern
Fabien Praz, MD, fabien.praz@insel.ch
- Recruiting
Kantonsspital Luzern LUKS
Lucerne
Stefan Toggweiler, MD, stefan.toggweiler@luks.ch
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Andreas Rück, MD, PhD, andreas.ruck@regionstockholm.se
About this study
Official title: PASTE: PASCAL for Tricuspid Regurgitation - a European Registry
This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in an observational fashion.
Read the detailed description
Tricuspid regurgitation (TR) is associated with high morbidity and mortality, but many patients are ineligible for surgical treatment due to age and co-morbidities. As a consequence, transcatheter treatment techniques have evolved over the last years. Leaflet repair is one of the most commonly used techniques and has recently gained commercial approval for dedicated TR treatment. The PASCAL (Edwards Lifesciences, Irvine, USA) offers the possibility for independent leaflet grasping and a central spacer can bridge larger coaptation gaps. The hitherto evidence is mainly based on compassionate use data. This study aims to report the first commercial use in a multicenter study with a large patient cohort und long-term follow-up.
Aim of the study is to investigate safety and efficacy of the PASCAL leaflet repair system in the treatment of TR in a commercial use setting.
Study design is a multicenter, single-device, retro- and prospective, observational registry. All consecutive patients undergoing treatment with the PASCAL system for tricuspid regurgitation in a commercial setting are included.
- Conditions
- Tricuspid Regurgitation
- Being tested
- PASCAL leaflet repair system
- 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.
PASCAL leaflet repair systemDevice
transcatheter Implantation of one or more PASCAL devices in the tricuspid valve
| Study group | Role | What they receive |
|---|---|---|
| PASCAL | patients treated with PASCAL leaflet repair system in the treatment of TR in a commercial use setting Receives: Device: PASCAL leaflet repair system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of TR severity
TR ≤ grade 2+ (moderate)
Measured: 1 year
Secondary outcomes (11)
Rate of technical success
absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery
Measured: 1 day
Rate of procedural safety
Absence of periprocedural and in-hospital adverse events
Measured: 1 week
New York Heart Association (NYHA) functional class
Level of exertional dyspnea (I - IV)
Measured: 1 year
6-minute walk distance (6MWD)
physical capacity measured by 6MWD in meters
Measured: 1 year
NT-proBNP level
cardiac biomarker level (in pg/nl)
Measured: last available follow-up (at least 1 year after intervention)
right heart dimension
Right ventricular end-diastolic Diameter (in mm)
Measured: 1 year
right heart function
tricuspid annular plane systolic excursion (TAPSE, in mm)
Measured: 1 year
tricuspid regurgitation severity
TR severity grading on a five-grade scheme (1-5)
Measured: last available follow-up (at least 1 year after intervention)
transtricuspid gradient
transvalvular antegrade gradient over tricuspid valve (in mmHg)
Measured: 1 year
pulmonary artery pressure (PAP)
estimated PAP by echocardiography (in mmHg)
Measured: 1 year
inferior vena cava (IVC) dimension
IVC Diameter during expiration (in mm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start5 May 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Jörg Hausleiter, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328284
- Sponsor's protocol ID
- 21-0385
- Acronym
- PASTE
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wild MG, Stolz L, Rosch S, Rudolph F, Goebel B, Koll B, von Stein P, Rottbauer W, Rassaf T, Beucher H, Kraus M, Kassar M, Geisler T, Ruck A, Ferreira-Martins J, Toggweiler S, Sagmeister P, Westermann D, Stocker TJ, Weckbach LT, Nabauer M, Settergren M, Dawkins S, Kister T, Praz F, Vorpahl M, Konstandin MH, Ludike P, Kessler M, Iliadis C, Kalbacher D, Lauten P, Gercek M, Besler C, Lurz P, Hausleiter J; PASTE Investigators. Transcatheter Valve Repair for Tricuspid Regurgitation: 1-Year Results From a Large European Real-World Registry. J Am Coll Cardiol. 2025 Jan 28;85(3):220-231. doi: 10.1016/j.jacc.2024.10.068. Epub 2024 Oct 28.
PubMed 39466215
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PASTE: PASCAL for Tricuspid Regurgitation - a European Registry
- ClinicalTrials.gov ID
- NCT05328284
- Acronym / sponsor ID
- PASTE / 21-0385
- Conditions
- Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 14 Apr 2022 (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.
This study aims to investigate the safety and efficacy of the PASCAL leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating Centers in an observational fashion.
Detailed description
Tricuspid regurgitation (TR) is associated with high morbidity and mortality, but many patients are ineligible for surgical treatment due to age and co-morbidities. As a consequence, transcatheter treatment techniques have evolved over the last years. Leaflet repair is one of the most commonly used techniques and has recently gained commercial approval for dedicated TR treatment. The PASCAL (Edwards Lifesciences, Irvine, USA) offers the possibility for independent leaflet grasping and a central spacer can bridge larger coaptation gaps. The hitherto evidence is mainly based on compassionate use data. This study aims to report the first commercial use in a multicenter study with a large patient cohort und long-term follow-up.
Aim of the study is to investigate safety and efficacy of the PASCAL leaflet repair system in the treatment of TR in a commercial use setting.
Study design is a multicenter, single-device, retro- and prospective, observational registry. All consecutive patients undergoing treatment with the PASCAL system for tricuspid regurgitation in a commercial setting are included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PASCAL | – | Device: PASCAL leaflet repair systempatients treated with PASCAL leaflet repair system in the treatment of TR in a commercial use setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients that have undergone transcatheter tricuspid valve repair with the PASCAL system since its commercial approval in 02/2019 at the participating centres shall be included in the study.
Key inclusion criteria (1 listed)
- Patients treated with the PASCAL system for tricuspid regurgitation in a commercial setting
Key exclusion criteria (1 listed)
- Patient age < 18 years
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 |
|---|---|---|
| PASCAL leaflet repair systemtranscatheter Implantation of one or more PASCAL devices in the tricuspid valve | Device | PASCAL |
Primary outcome
Change of TR severity
Time frame: 1 year
TR ≤ grade 2+ (moderate)
11 secondary outcomes
Rate of technical success
Time frame: 1 day
Rate of procedural safety
Time frame: 1 week
New York Heart Association (NYHA) functional class
Time frame: 1 year
6-minute walk distance (6MWD)
Time frame: 1 year
NT-proBNP level
Time frame: last available follow-up (at least 1 year after intervention)
right heart dimension
Time frame: 1 year
right heart function
Time frame: 1 year
tricuspid regurgitation severity
Time frame: last available follow-up (at least 1 year after intervention)
transtricuspid gradient
Time frame: 1 year
pulmonary artery pressure (PAP)
Time frame: 1 year
inferior vena cava (IVC) dimension
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 39466215Wild MG, Stolz L, Rosch S, Rudolph F, Goebel B, Koll B, von Stein P, Rottbauer W, Rassaf T, Beucher H, Kraus M, Kassar M, Geisler T, Ruck A, Ferreira-Martins J, Toggweiler S, Sagmeister P, Westermann D, Stocker TJ, Weckbach LT, Nabauer M, Settergren M, Dawkins S, Kister T, Praz F, Vorpahl M, Konstandin MH, Ludike P, Kessler M, Iliadis C, Kalbacher D, Lauten P, Gercek M, Besler C, Lurz P, Hausleiter J; PASTE Investigators. Transcatheter Valve Repair for Tricuspid Regurgitation: 1-Year Results From a Large European Real-World Registry. J Am Coll Cardiol. 2025 Jan 28;85(3):220-231. doi: 10.1016/j.jacc.2024.10.068. Epub 2024 Oct 28.
- 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.
Mirjam Wild, MD contact
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation, run by LMU Klinikum at 14 sites in 3 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 1 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Switzerland, Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörg Hausleiter, MD (+49 89 4400 72360, joerg.hausleiter@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of TR severity (time frame: 1 year). 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 NCT05328284, which also lists 1 linked publication.
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 14 Apr 2022.