Clinical trials: Aortic Valve Surgery, active
Cardiac Surgery, Peri Operative Medicine
Risk Factors of Atrial Fibrillation After Cardiac Surgery
Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death.
- Conditions
- Cardiac Surgery, Peri Operative Medicine, Thoracic Surgery, Cardiopulmonary Bypass
- Trial name
- PFAS (NCT07625033)
- Where
- France
- Volunteers
- 918 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
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
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
Paravalvular Aortic Regurgitation
PARADIGM: Amplatzer Valvular Plug for PVL Closure
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant…
- Trial name
- PARADIGM (NCT04489823)
- Testing
- AVP III
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
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
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Valve Heart Disease, Coronary Artery Disease
Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery
Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019.
- Conditions
- Valve Heart Disease, Coronary Artery Disease, Coronary Heart Disease, Aortic Diseases
- Trial name
- NCT07662317
- Testing
- Cardiac surgey
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA)
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
Post-operative atrial fibrillation (POAF) is a frequent complication of surgical aortic valve replacement, affecting 38 to 63% of patients, and increasing risks of stroke, heart failure, and long-term mortality.
- Conditions
- Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA), Heart Failure, Myocardial Infarction (MI)
- Trial name
- VAGASTIMA-PILT (NCT07891390)
- Testing
- tVNS session on the left earlobe
- Where
- 3 sites in France
- Volunteers
- 64 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Aortic Stenosis
TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with…
- Trial name
- NOSCAR-TAVI (NCT07515768)
- Testing
- transcathter aortic valve implantation
- Volunteers
- 404 people
- Sponsor
- Medical University of Warsaw
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Aortic Valve Stenosis
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or…
- Trial name
- DEDICATE (NCT03112980)
- Testing
- Transcatheter aortic valve implantation, Surgical aortic valve replacement
- Where
- 43 sites in Germany
- Volunteers
- 1,414 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Heart Valve Diseases, Aortic Valve Stenosis
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique…
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic
- Trial name
- CORONATE (NCT05714293)
- Testing
- CT scan with contrast medium
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ischemic Heart Disease, Aortic Stenosis, Severe
Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass.
- Conditions
- Ischemic Heart Disease, Aortic Stenosis, Severe, Aortic Insufficiency, Mitral Stenosis
- Trial name
- NCT06377449
- Testing
- Ultrasound examination of the lungs
- Where
- Russia
- Volunteers
- 186 people
- Sponsor
- Saint Petersburg State University, Russia
AORTIC VALVE DISEASES, Valve-in-valve Procedures
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic…
- Conditions
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement, Valve Disease, Aortic
- Trial name
- REVIVAL (NCT07524595)
- Testing
- Hydra THV Series, Sapien THV Series and MyVal THV Series
- Where
- Ireland
- Volunteers
- 111 people
- Sponsor
- National University of Ireland, Galway, Ireland
Coronary Artery Disease, Aortic Valve Disease
Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Open heart surgery, including coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) is associated with a significant risk of mortality.
- Trial name
- GLORIOUS-II (NCT05635227)
- Testing
- Dexamethasone phosphate, Isotonic sodium chloride (0.9%), Olanzapine 10 MG
- Where
- Denmark
- Volunteers
- 1,200 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Type A Aortic Dissection, Ascending Aortic Dissection
Outcomes of Aortic Dissection Repair
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity.
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch
- Trial name
- STAAD (NCT05927090)
- Testing
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR), Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Centre Cardiologique du Nord
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI).
- Trial name
- TAVISAR (NCT05261204)
- Testing
- Transcatheter Aortic Valve Implantation, Bioprothesis, Sutureless
- Where
- France
- Volunteers
- 4,000 people
- Sponsor
- Centre Cardiologique du Nord