Clinical trials: Transfemoral Implantation of Aortic Valves
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
Severe Symptomatic Aortic Stenosis
Evaluation of Length of Stay After TF-TAVI
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002.
- Trial name
- FAST-TAVI (NCT02956915)
- Testing
- Transfemoral Transcatheter aortic valve implantation
- Where
- 5 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Rouen
Quality of Life
Health-related QoL Following TAVI TAo, TAVI TF and AVR
The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and…
- Trial name
- NCT03583398
- Testing
- transcatheter aortic valve implantation, surgical aortic valve replacement
- Volunteers
- 97 people
- Sponsor
- Medical University of Gdansk
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Symptomatic Aortic Stenosis
Portico TAVI Implant With Transfemoral Delivery System
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
- Trial name
- NCT01493284
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 14 sites in Australia, Denmark and 3 more
- Volunteers
- 222 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Aortic Stenosis
Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to…
- Trial name
- EASE-IT-TF (NCT02760771)
- Testing
- with BAV, without BAV
- Where
- Germany
- Volunteers
- 196 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Heart Valve Diseases, Complication,Postoperative
Fast Track Concept for Transfemoral TAVI
Transcatheter aortic valve implantation (TAVI) in high-risk patients with severe aortic valve stenosis has developed itself until today as an established minimally invasive alternative procedure worldwide, with a focus on the…
- Trial name
- NCT04792827
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Hospital Schleswig-Holstein
Aortic Valve Stenosis
Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation
Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.
- Trial name
- TRANSAX (NCT04274751)
- Testing
- Transcatheter aortic valve implantation
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Ignacio J. Amat Santos
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Anesthesia, Analgesia
Transversus Abdominis Plan (TAP) Block for Transcatheter Aortic Valve Implantation (TAVI)
Hemodynamic stability is the main goal of the anesthetic method during Transcatheter Aortic Valve Implantation (TAVI). Pain during the procedure may cause patients to move therefore hemodynamic instability.
- Conditions
- Anesthesia, Analgesia, Block, Aortic Valve Stenosis
- Trial name
- NCT06762288
- Testing
- Ultrasound, Local anesthesia and sedation
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Istanbul University - Cerrahpasa
Aortic Valve Stenosis
Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II
Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future…
- Trial name
- SCOPE II (NCT03192813)
- Testing
- Symetis ACURATE neo™ transfemoral TAVI system, Medtronic CoreValve Evolut R TAVI System
- Where
- 23 sites in Denmark, France and 4 more
- Volunteers
- 796 people
- Sponsor
- Ceric Sàrl
Coronary Angiography, Transcatheter Aortic Valve Replacement
Coronary Access After Supra-Annular THV Implantation
To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.
- Trial name
- CAN-ACCESS (NCT05075590)
- Testing
- Coronary Angiography
- Where
- 4 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- University of British Columbia
Aortic Valve Stenosis
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Collect and evaluate the long term safety data.
- Trial name
- NCT01497418
- Where
- 2 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Transcatheter Aortic Valve Implantation
The Sentinel Registry
This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
- Trial name
- Sentinel (NCT05217888)
- Testing
- Sentinel
- Where
- 10 sites in South Korea
- Volunteers
- 158 people
- Sponsor
- Duk-Woo Park, MD
Transfemoral Implantation of Aortic Valves
CNAP in Heart Surgery
The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation.
- Trial name
- NCT01420484
- Testing
- different blood pressure intervals
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Heidelberg University
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortic Valve Stenosis
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI).
- Trial name
- CHOICE-CLOSURE (NCT04459208)
- Testing
- Manta, ProGlide
- Where
- Germany
- Volunteers
- 516 people
- Sponsor
- Helios Health Institute GmbH
Aortic Valve Stenosis
Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.
Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR).
- Trial name
- SCOPE I (NCT03011346)
- Testing
- Symetis ACURATE neo/TF transfemoral TAVI system, Edwards Sapien 3 Transcatheter Heart Valve
- Where
- 20 sites in Germany, Netherlands and 2 more
- Volunteers
- 739 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG