Clinical trials: Valve-in-valve Procedures
Outcomes, Body Temperature
Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
It is known that perioperative hypothermia can influence the postoperative outcome negatively. The most important complications are cardiac, increased blood loss with need for transfusion and a significantly increased wound…
- Trial name
- TIMI (NCT01176110)
- Testing
- LMA Perfect Temp
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Charite University, Berlin, Germany
Heart Failure, Aortic Stenosis
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study) Part I: Observational study to characterize…
- Trial name
- SCRABLES (NCT02856620)
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Christine Henri
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Low Flow, Low Gradient Aortic Stenosis
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis
LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing…
- Trial name
- LOW-TAVR (NCT06589063)
- Testing
- Transcatheter aortic valve replacement
- Where
- Italy
- Volunteers
- 1,350 people
- Sponsor
- University of Salerno
Heart Failure, Aortic Stenosis
Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure
The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.
- Trial name
- WiTAVi (NCT02628509)
- Testing
- cardiac devices
- Where
- France
- Volunteers
- 500 people
- Sponsor
- University Hospital, Lille
Hypertrophic Obstructive Cardiomyopathy
The Safety and Influencing Factors of Liwen Procedure in The Treatment of Hypertrophic Cardiomyopathy
Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but a small proportion of patients have complications after the operation.
- Trial name
- NCT06003478
- Testing
- Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)
- Where
- China
- Volunteers
- 486 people
- Sponsor
- Xijing Hospital
Preoperative Care, Preoperative Anxiety
The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety in Older Patients
The goal of this clinical feasibility study is to learn about the acceptability and feasibility of a music intervention in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure.
- Trial name
- fa-MIPA (NCT06173674)
- Testing
- Music intervention
- Where
- Belgium
- Volunteers
- 78 people
- Sponsor
- KU Leuven
Tetralogy of Fallot
Follow up of Post-repair Tetralogy of Fallot
Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past five decades, surgical repair has been performed with respectable results. However, relevant postoperative residues frequently remain.
- Trial name
- NCT00266188
- Where
- 14 sites in Germany
- Volunteers
- 406 people
- Sponsor
- Competence Network for Congenital Heart Defects
Coronary Artery Bypass Grafting, Heart Valve Disease
LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients
This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health…
- Conditions
- Coronary Artery Bypass Grafting, Heart Valve Disease, Aortic Aneurysm, Aortic Dissection
- Trial name
- cFT-LLM (NCT07521488)
- Testing
- LLM-Based Intelligent Health Management Assistant
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Beijing Anzhen Hospital
Heart Valve Diseases
Methods Study to Evaluate Use of Cardiac Ultrasound to Assess Heart Valve Abnormality in People.
Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in people.
- Trial name
- NCT00359489
- Testing
- cardiac echosonography
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Atrial Fibrillation
Prophylactic Pulmonary Vein Isolation Study
This study is being done to learn the effects of the Pulmonary Vein Isolation in patients that are at high risk to developing, but do not have a documented history of atrial fibrillation.
- Trial name
- NCT00587899
- Testing
- Pulmonary Vein Isolation
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Mayo Clinic
Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease.
- Trial name
- ASSEE-SHD (NCT07848152)
- Where
- 11 sites in China
- Volunteers
- 2,200 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Congenital Disorders
Children and Adolescents Receiving Mechanical and Prosthetic Valves
The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event …
- Trial name
- NCT00268008
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's Healthcare of Atlanta
Neurobehavioral Manifestations
Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures
Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of post-operative cognitive dysfunction (POCD).
- Trial name
- NCT01953068
- Where
- 2 sites in Finland
- Volunteers
- 18 people
- Sponsor
- Tampere University Hospital
Structural Valve Deterioration, Structural Valve Degeneration
The ReTAVI Prospective Observational Registry
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a…
- Conditions
- Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction
- Trial name
- NCT05601453
- Testing
- Elective redo transcatheter aortic valve implantation (redo-TAVI)
- Where
- 62 sites in Austria, Canada and 9 more
- Volunteers
- 250 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Computed Tomography-guided Nasotracheal Intubation, The Space Where the Tube Will be Passed in the Internal Nasal Valve Region
Computed Tomography-Guided Nasotracheal Intubation Procedure
Background: Nasotracheal intubation can lead to severe complications like epistaxis with excessive bleeding. The advancement difficulty of the tube faced during nasal intubation is one of the fundamental causes of this condition.
- Trial name
- NCT05525754
- Testing
- computed tomography-guided nasotracheal intubation
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- TC Erciyes University
Mitral Regurgitation
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in…
- Trial name
- ISAR-CLIP (NCT01431222)
- Testing
- percutaneous treatment by implanting a Mitra Clip device
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Hypertrophic Cardiomyopathy (HCM)
Individualized Exercise Training in Hypertrophic Cardiomyopathy
Exercise intervention trials in patients with hypertrophic cardiomyopathy (HCM) have demonstrated an association with improvement in resting and exercise hemodynamics, ventricular remodeling, and anxiety/depression.
- Trial name
- GET-FIT HCM (NCT07835854)
- Testing
- Exercise Intervention, Physical Activity Handout
- Volunteers
- 60 people
- Sponsor
- Oregon Health and Science University
Haemoptysis
Endobronchial Valves in Inoperable Patients With Haemoptysis
Massive haemoptysis is a life-threatening condition which is commonly seen in patients who have previously had pulmonary tuberculosis.
- Trial name
- NCT02816229
- Testing
- Insertion of endobronchial valve
- Volunteers
- 20 people
- Sponsor
- University of Stellenbosch