Clinical trials: TAVI
Aortic Stenosis, Mitral Regurgitation
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- MASTER-TAVI II (NCT07623083)
- Volunteers
- 300 people
- Sponsor
- Josep Rodes-Cabau
Aortic Valve Stenosis
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a…
- Trial name
- TASQ (NCT03186339)
- Testing
- TAVI, SAVR, MM
- Where
- 10 sites in Austria, Canada and 5 more
- Volunteers
- 272 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis
The Asian Pacific TAVR Multicenter Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population
- Trial name
- AP TAVR (NCT02195102)
- Testing
- Transcatheter aortic valve Replacement
- Where
- 10 sites in China, Japan and 6 more
- Volunteers
- 2,000 people
- Sponsor
- Michael Kang-Yin Lee, MD
Delirium, Post-Op Complication
Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement.
- Conditions
- Delirium, Post-Op Complication, Anesthesia, Aortic Valve Disease
- Trial name
- DELIRIUMTAVI (NCT03323619)
- Testing
- anesthesia type
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Central Hospital, Nancy, France
Aortic Valve Stenosis
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
To evaluate the long-term results after transcatheter aortic valve replacement
- Trial name
- CSI-TAVR (NCT02162069)
- Testing
- CE certified transcatheter ( aortic valve replacement)
- Where
- Germany
- Volunteers
- 843 people
- Sponsor
- University of Ulm
Aortic Stenosis, Conduction Defect, Cardiac
Ventricular Pacing Rate in Follow-up of Patients Treated With Definitive PM Implantation Post TAVI
The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI).
- Trial name
- P-P-P-TAVI (NCT06499428)
- Where
- Italy
- Volunteers
- 67 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07121907)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Aortic Valve Disease
Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis
The overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or TAVI by retrieving data from the main social security carriers in Austria for the years 2010-2020.
- Trial name
- NCT05912660
- Testing
- Aortic Valve Replacement
- Volunteers
- 18,882 people
- Sponsor
- Medical University of Vienna
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, Cerebral Ischaemic Injury
Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）
Transcatheter aortic valve replacement (TAVR) has become the most anticipated treatment method in the cardiovascular field in recent years, experiencing rapid development.
- Trial name
- PISTNT (NCT07087379)
- Testing
- Intensive statin treatment
- Volunteers
- 500 people
- Sponsor
- Pan Xiangbin
Aortic Stenosis
Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR
To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- HBCR-TAVR (NCT04166682)
- Testing
- Home-based cardiac rehabilitation, Routine care
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Transcatheter Aortic Valve Replacement
Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)
The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a…
- Trial name
- AVATAR (NCT02735902)
- Testing
- Vitamin K antagonist or direct oral anticoagulant treatment, Aspirin
- Where
- 6 sites in France
- Volunteers
- 170 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Symptomatic Aortic Stenosis
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed…
- Trial name
- CoreValveIndia (NCT02759237)
- Testing
- CoreValve System Family
- Where
- India
- Volunteers
- 3 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Valve Stenosis, Aortic Valve Stenosis
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully…
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- REAC-TAVI2 (NCT05283356)
- Testing
- Ticagrelor 60mg
- Where
- Spain
- Volunteers
- 1,206 people
- Sponsor
- Fundacin Biomedica Galicia Sur
Acute Ischemic Stroke, Acute Renal Injury
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation
The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS)…
- Trial name
- PAIR-TAVI (NCT05145283)
- Testing
- Conestat alfa (Ruconest®), NaCl 0.9%)
- Where
- 2 sites in Switzerland
- Volunteers
- 141 people
- Sponsor
- University Hospital, Basel, Switzerland
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
Aortic Stenosis
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05866640
- Testing
- F2 filter and delivery system
- Where
- Georgia
- Volunteers
- 10 people
- Sponsor
- EnCompass Technologies, Inc.
Hypotension During Surgery, Prevention of Hypotension
"Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management
The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.
- Trial name
- NCT06347211
- Testing
- Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Attikon Hospital
Bicuspid-related Aortopathy, Aortic Stenosis
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)
Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery.
- Trial name
- PROSPERO-TAVI (NCT06248294)
- Testing
- CT follow-up
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Catania