Clinical trials: Transcatheter Aortic Valve Replacement
Bradycardia
Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation.
- Trial name
- NCT03180073
- Testing
- Ziopatch Pre discharge, Ziopatch at Discharge, Ziopatch at 2 months
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis, Heart Valve Diseases
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)
Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female…
- Trial name
- RHEIA (NCT04160130)
- Testing
- Transcatheter aortic valve replacement
- Where
- 48 sites in Austria, Belgium and 10 more
- Volunteers
- 432 people
- Sponsor
- Optimapharm
Aortic Valve Stenosis, Aortic Diseases
PENG Block forTranscatheter Aortic Valve Implantation
Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas…
- Trial name
- NCT05904912
- Testing
- Postoperative analgesia management, PENG-Bupivacaine, Local infiltration-Bupivacaine
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Medipol University
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Aortic Valve Stenosis
The Prospective Segeberg TAVI Registry
A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany
- Trial name
- POST-TAVI (NCT03192774)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Segeberger Kliniken GmbH
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
Aortic Stenosis, Coronary Artery Disease
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention…
- Conditions
- Aortic Stenosis, Coronary Artery Disease, TAVI, PCI
- Trial name
- TAVI-PCI (NCT04310046)
- Testing
- PCI before TAVI, PCI after TAVI
- Where
- 48 sites in Austria, France and 4 more
- Volunteers
- 986 people
- Sponsor
- University of Zurich
Aortic Valve Stenosis, Cardiovascular Diseases
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic…
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-4 (NCT06449469)
- Testing
- Rivaroxaban, Acetylsalicylic acid, Clopidogrel
- Where
- 2 sites in Denmark
- Volunteers
- 352 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
Alwide Plus China Post-market Clinical Investigation
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve…
- Trial name
- NCT07304427
- Where
- 4 sites in China
- Volunteers
- 75 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Transcatheter Aortic Valve Implantation (TAVI), Blood Transfusion
Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
Periprocedural bleeding events are frequent during transcatheter aortic valve implantation (TAVI), mainly driven by vascular complications and are associated to a worse prognosis.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Blood Transfusion, AKI, Prognosis
- Trial name
- TRITAVI (NCT03740425)
- Testing
- Blood Transfusion
- Where
- Italy
- Volunteers
- 3,235 people
- Sponsor
- G. d'Annunzio University
Aortic Stenosis, Transcatheter Aortic Valve Replacement
EffecTAVI Registry
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
- Trial name
- NCT05235555
- Testing
- Transcatheter heart valve (THV) with CE approval
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Federico II University
Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited.
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Trial name
- LATETAVI (NCT07414485)
- Testing
- retrospective health data collection
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Transcatheter Aortic Valve Replacement, Procedural Sedation
Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation
Aortic valve stenosis is the most common valvular heart disease in the developed world, affecting 3,9% of population over 70 years of age.
- Trial name
- NCT03747432
- Testing
- Propofol, Dexmedetomidine
- Where
- Slovenia
- Volunteers
- 70 people
- Sponsor
- University Medical Centre Ljubljana
Atrial Fibrillation, Aortic Stenosis
Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in AF Undergoing TAVI
Study category and Rationale Clinical study, Category A. Clinical Phase: Post market study Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral anticoagulation and provides at the same time an at…
- Trial name
- TAVI/LAAO (NCT03088098)
- Testing
- LAAO
- Where
- Switzerland
- Volunteers
- 81 people
- Sponsor
- University of Zurich
Transcatheter Aortic Valve Implantation, Physiological Pacing
Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined…
- Conditions
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block
- Trial name
- PHYS-TAVI (NCT04482816)
- Testing
- Physiological pacing, Right ventricular pacing
- Where
- Spain
- Volunteers
- 24 people
- Sponsor
- Josep Lluis Mont Girbau
Aortic Valve Disorder
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the…
- Trial name
- NCT02696226
- Testing
- SAVR Warfarin, SAVR Aspirin, TAVR Warfarin and clopidogrel
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic…
- Trial name
- TAVI (NCT06154642)
- Testing
- Determination of arterial compliance using blood pressure waveform analysis, Measurement of plasma Vascular Endothelium Growth Factor, Skin temperature gradient
- Where
- Switzerland
- Volunteers
- 21 people
- Sponsor
- University Hospital, Geneva