Clinical trials: Trans Aortic Valve Implantation (TAVI)
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Sarcopenia, Chronic Heart Failure
Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before TAVI
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.
- Trial name
- PRESAR-HF (NCT03153774)
- Testing
- Assessment of sarcopenia prevalence
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Clermont-Ferrand
Aortic Stenosis, Right Bundle-Branch Block
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients…
- Trial name
- TAVI-PACE (NCT05889208)
- Testing
- Prophylactic pacemaker implantation
- Volunteers
- 320 people
- Sponsor
- Aalborg University Hospital
Aortic Stenosis
CAN3T - Canadian TAVI Triage Tool
The goal of this trial is to see if a tool that may reduce wait times will reduce bad outcomes in participants on the TAVI waitlist.
- Trial name
- CAN3T (NCT06551610)
- Testing
- Triage Tool
- Volunteers
- 5,060 people
- Sponsor
- Sunnybrook Health Sciences Centre
Severe Aortic Stenosis, Cardiogenic Shock
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk…
- Conditions
- Severe Aortic Stenosis, Cardiogenic Shock, Cardiogenic Shock, ECMO, Trans-catheter Aortic Valve Implantation
- Trial name
- PROTECT-TAVR (NCT07309029)
- Testing
- Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Atlantic Health System
Symptomatic Aortic Stenosis, Eligible for Transcatheter Aortic Valve Replacement
Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis
ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial. The objective of this study is to demonstrate superiority of a strategy of anticoagulation with apixaban (Anti-Xa Group) as compared to the current…
- Trial name
- ATLANTIS (NCT02664649)
- Testing
- Apixaban, Standard of care
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 1,510 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Stenosis, Trans-catheter Aortic Valve Implantation
Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary arteries by the valve…
- Conditions
- Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Commissural Alignment
- Trial name
- ALIGN-EFX (NCT07217691)
- Testing
- Implantation of Evolut FX pluss TAVI device from Medtronic in LAO 25, Implantation of Evolut FX pluss TAVI device from Medtronic in patient specific degree.
- Volunteers
- 40 people
- Sponsor
- Oslo University Hospital
Transapical Transcatheter Aortic Valve Implantation
Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system.
- Trial name
- NCT01722591
- Testing
- Cardiapex device
- Where
- 2 sites in Germany
- Volunteers
- 38 people
- Sponsor
- Cardiapex Ltd.
Aortic Valve Disease
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day…
- Trial name
- REBOOT (NCT02668484)
- Testing
- repositionable valve prosthesis, balloon-expandable valve prosthesis
- Where
- 3 sites in Germany, Italy
- Volunteers
- 116 people
- Sponsor
- LMU Klinikum
Conduction Disturbance, Trans Aortic Valve Implantation (TAVI)
Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study
Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and…
- Trial name
- STIM TAVI MS (NCT04906837)
- Testing
- Trans aortic valve implantation
- Where
- France
- Volunteers
- 197 people
- Sponsor
- Association de Recherche en Cardiologie des Alpes
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
Aortic Valve Stenosis
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI)…
- Trial name
- NCT01721642
- Testing
- Apica Cardiovascular ASC Access, Stability and Closure Device
- Volunteers
- 31 people
- Sponsor
- Apica Cardiovascular Limited
Postoperative Delirium
Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications.
- Trial name
- NCT02585128
- Testing
- Delirium assessment, MMSE (Mini Mental State Examination), Barthel index
- Where
- Switzerland
- Volunteers
- 201 people
- Sponsor
- Cardiocentro Ticino
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles