Tricuspid Regurgitation
Conditions
Brief 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.
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.
Interventions
DEVICEPASCAL leaflet repair system
transcatheter Implantation of one or more PASCAL devices in the tricuspid valve
Sponsors
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients treated with the PASCAL system for tricuspid regurgitation in a commercial setting
Exclusion criteria
* Patient age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of TR severity | 1 year | TR ≤ grade 2+ (moderate) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of procedural safety | 1 week | Absence of periprocedural and in-hospital adverse events |
| New York Heart Association (NYHA) functional class | 1 year | Level of exertional dyspnea (I - IV) |
| 6-minute walk distance (6MWD) | 1 year | physical capacity measured by 6MWD in meters |
| NT-proBNP level | last available follow-up (at least 1 year after intervention) | cardiac biomarker level (in pg/nl) |
| right heart dimension | 1 year | Right ventricular end-diastolic Diameter (in mm) |
| Rate of technical success | 1 day | absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery |
| tricuspid regurgitation severity | last available follow-up (at least 1 year after intervention) | TR severity grading on a five-grade scheme (1-5) |
| transtricuspid gradient | 1 year | transvalvular antegrade gradient over tricuspid valve (in mmHg) |
| pulmonary artery pressure (PAP) | 1 year | estimated PAP by echocardiography (in mmHg) |
| inferior vena cava (IVC) dimension | 1 year | IVC Diameter during expiration (in mm) |
| right heart function | 1 year | tricuspid annular plane systolic excursion (TAPSE, in mm) |
Countries
Germany, Sweden, Switzerland
Contacts
Primary ContactJörg Hausleiter, MD
Backup ContactMirjam Wild, MD
Outcome results
None listed