An observational study in Tricuspid Regurgitation, sponsored by LMU Klinikum. Status unknown at 14 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by LMU Klinikum · Observational
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.
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.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 96 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →LMU Klinikum is the lead sponsor of 51 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
patients treated with PASCAL leaflet repair system in the treatment of TR in a commercial use setting
Device: PASCAL leaflet repair system
transcatheter Implantation of one or more PASCAL devices in the tricuspid valve
Change of TR severity
TR ≤ grade 2+ (moderate)
Time frame: 1 year
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
Time frame: 1 day
Rate of procedural safety
Absence of periprocedural and in-hospital adverse events
Time frame: 1 week
New York Heart Association (NYHA) functional class
Level of exertional dyspnea (I - IV)
Time frame: 1 year
6-minute walk distance (6MWD)
physical capacity measured by 6MWD in meters
Time frame: 1 year
NT-proBNP level
cardiac biomarker level (in pg/nl)
Time frame: last available follow-up (at least 1 year after intervention)
right heart dimension
Right ventricular end-diastolic Diameter (in mm)
Time frame: 1 year
right heart function
tricuspid annular plane systolic excursion (TAPSE, in mm)
Time frame: 1 year
tricuspid regurgitation severity
TR severity grading on a five-grade scheme (1-5)
Time frame: last available follow-up (at least 1 year after intervention)
transtricuspid gradient
transvalvular antegrade gradient over tricuspid valve (in mmHg)
Time frame: 1 year
pulmonary artery pressure (PAP)
estimated PAP by echocardiography (in mmHg)
Time frame: 1 year
inferior vena cava (IVC) dimension
IVC Diameter during expiration (in mm)
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tricuspid Valve Insufficiency→
LMU Klinikum