Clinical trials: Aortic Valve Surgery
Aortic Stenosis
Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery
The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical closure of LAA in patients undergoing aortic valve replacement.
- Trial name
- LAA-CLOSURE (NCT02321137)
- Testing
- Surgical closure of left atrial appendage, No closure of left atrial appendage
- Where
- 4 sites in Finland, Netherlands
- Volunteers
- 1,040 people
- Sponsor
- University of Turku
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
Prosthetic Valve Thrombosis
Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation
This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging.
- Trial name
- RESOLVE (NCT02318342)
- Testing
- Warfarin
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability
Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction, Electro-acupuncture
- Trial name
- FRESH-T (NCT07365345)
- Testing
- electrical acupoint stimulation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Air Force Military Medical University, China
Femoral Artery Injury, Aortic Valve Insufficiency
Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter…
- Trial name
- MANTA-MICS (NCT04802200)
- Testing
- Data collect
- Where
- France
- Volunteers
- 204 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Aortic Valve Disease
Ross for Valve Replacement in AduLts Trial
This study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure versus conventional aortic valve replacement using a biologic or mechanical heart valve.
- Trial name
- REVIVAL (NCT03798782)
- Testing
- Ross procedure, Conventional aortic valve replacement
- Where
- Canada
- Volunteers
- 43 people
- Sponsor
- Population Health Research Institute
Aortic Valve Disease, Mitral Valve Disease
VIenna Pilot Study for Automated Annular Suturing Technology
The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology.
- Trial name
- VIP-RAM (NCT04659655)
- Testing
- automated annular suturing
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Medical University of Vienna
Aortic Valve Stenosis, Bicuspid Aortic Valve
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVE-IT (NCT06817148)
- Testing
- transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Stenosis
PERIGON Pivotal Trial
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
- Trial name
- PERIGON (NCT02088554)
- Testing
- Model 400 aortic valve bioprosthesis
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 1,312 people
- Sponsor
- Medtronic Cardiac Surgery
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
REVIVE-FR Registry
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis
- Trial name
- NCT07885761
- Testing
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
- Trial name
- NCT07205341
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HemoCept Inc.
Transcatheter Aortic Valve Replacement, Cardiac Valve Annuloplasty
Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery
The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery.
- Trial name
- ACTPOC (NCT04785885)
- Testing
- iStat Handheld Blood Analyzer, Hemochron
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rhode Island Hospital
Ischaemic Heart Disease, Aortic Stenosis
Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.
To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without…
- Trial name
- PRECON2 (NCT02053818)
- Testing
- Remifentanil, Sufentanil
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- Aarhus University Hospital
Aortic Valve Replacement
Homoeopathic Association in Aortic Valve Surgery
Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation…
- Trial name
- OMEO (NCT00774293)
- Testing
- Arnica and Bryonia
- Where
- France
- Volunteers
- 92 people
- Sponsor
- BOIRON
Surgery, Survival, Prosthesis
15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).
- Conditions
- Surgery, Survival, Prosthesis, Valve Heart Disease
- Trial name
- ANDALVALVE (NCT03239509)
- Testing
- bioprosthesis implantation between 2000-2015, mechanical prosthesis implantation between 2000-2015
- Where
- 7 sites in Spain
- Volunteers
- 1,200 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Atrial Fibrillation, Coronary Artery Disease
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease
- Trial name
- CAREBANK (NCT03444259)
- Testing
- Cardiac surgery
- Where
- Finland
- Volunteers
- 1,001 people
- Sponsor
- University of Turku
Aortic Stenosis, Multi Vessel Coronary Artery Disease
The TransCatheter Valve and Vessels Trial
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and…
- Conditions
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG
- Trial name
- TCW (NCT03424941)
- Testing
- FFR-guided PCI and TAVI, CABG and SAVR
- Where
- 20 sites in Austria, Denmark and 8 more
- Volunteers
- 172 people
- Sponsor
- Maatschap Cardiologie Zwolle