Cardiac Catheterization Clinical Trial
Official title:
Evaluation of the Safety, Efficacy and Cost-effectiveness of Transcatheter Tricuspid Valve Repair in Patients With Severe Tricuspid Regurgitation in the Netherlands.
This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC alone in patients with symptomatic severe Tricuspid Regurgitation (TR) in the Netherlands.
Tricuspid valve regurgitation (TR) is a common heart valve disease associated with mortality, heart failure hospitalization (HHF) and a significant negative impact on quality of life (QoL). The prevalence of moderate or severe TR in the Netherlands is estimated at 0.55% and becoming more prevalent. Surgery is rarely performed, because in-hospital mortality is high and there is little evidence for the efficacy. The majority of patients does therefore entirely dependent on treatment with heart failure medication. However, a subset of these patients experience (progressive) symptoms of refractory congestive heart failure despite the SOC with heart failure medication. Transcatheter Tricuspid Valve repair (TTVr) offers several new strategies to address severe TR; one promising technique to treat patients with symptomatic severe TR is edge-to-edge tricuspid valve (TV) repair through leaflet approximation. Edge-to-edge TTVr may provide an elegant alternative treatment for many patients, because it is less burdensome due to the minimally invasive nature. Moreover, multiple single-arm trials already reported promising outcomes in terms of efficacy and safety, and the technique is very similar to Transcatheter Mitral Valve repair (TMVr), with yet proven feasibility, efficacy and safety. The aim of this study is to evaluate the safety, efficacy and cost-effectiveness of TTVr for patients with symptomatic severe TR despite the SOC and high/prohibitive surgical risk in the Netherlands. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05539092 -
The Effect of Changing Angle of Bed on Pain Severity and Vascular Complications Among Cardiac Catheterization Patients
|
N/A | |
Completed |
NCT02074527 -
CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography
|
||
Completed |
NCT01157338 -
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
|
N/A | |
Terminated |
NCT00850473 -
PET/CT Study in the Diagnosis of Coronary Plaque
|
N/A | |
Completed |
NCT03645837 -
Rapid Clamp Release Post Trans-radial Cardiac Catheterization
|
N/A | |
Completed |
NCT04404257 -
Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation
|
N/A | |
Recruiting |
NCT03555500 -
Fasting or Non Fasting for Cardiac Catheterization
|
N/A | |
Not yet recruiting |
NCT06134141 -
The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital
|
||
Recruiting |
NCT05941013 -
Ultrasound-detectable Endotracheal Tube: a Feasibility Study
|
N/A | |
Recruiting |
NCT05632640 -
Post Anesthesia Care Unit (PACU) Weighted Blanket Study
|
N/A | |
Unknown status |
NCT00838175 -
Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access
|
N/A | |
Completed |
NCT03243942 -
Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement
|
Phase 2 | |
Completed |
NCT01155167 -
Topical Radial Artery Vasodilation
|
Phase 2/Phase 3 | |
Completed |
NCT04258007 -
Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization
|
N/A | |
Withdrawn |
NCT00825331 -
Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)
|
N/A | |
Recruiting |
NCT05225077 -
Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients
|
Phase 4 | |
Completed |
NCT05117359 -
Transcatheter Para-Valvular Leak Closures
|
||
Recruiting |
NCT00849940 -
Validation of Brain Oxygenation Monitor on Pediatric Patients
|
N/A | |
Active, not recruiting |
NCT05364463 -
Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation (RadialHUS)
|
N/A | |
Completed |
NCT03245255 -
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
|
Phase 2 |