Clinical trials: TAVI, active
Aortic Stenosis
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation…
- Trial name
- NCT06891079
- Testing
- Videodensitometric guided, Stand of care guided
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- Xijing Hospital
Atrial Fibrillation
Pharmacological Intervention to Prevent NOAF After TAVR
The goal of this clinical trial is to learn if amiodarone or metoprolol works to prevent new-onset atrial fibrillation (AF) in patients who develop certain atrial arrhythmias after transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT07519161
- Testing
- Metoprolol succinate, Amiodarone
- Volunteers
- 198 people
- Sponsor
- Shanghai East Hospital
Left Bundle-Branch Block, Aortic Valve Stenosis
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization…
- Trial name
- COME-TAVI (NCT03303612)
- Testing
- Pacemaker implant, Transcutaneous cardiac monitor
- Where
- 10 sites in Canada, France
- Volunteers
- 250 people
- Sponsor
- Montreal Heart Institute
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 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 Valve Stenosis
Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Symptomatic Native Aortic Valve Stenosis (BEST)
Over the last years, several randomized studies comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) have established TAVI as a treatment option in symptomatic patients with aortic…
- Trial name
- BEST (NCT05454150)
- Testing
- balloon-expandable valve, self-expanding valve
- Where
- 21 sites in France
- Volunteers
- 1,960 people
- Sponsor
- University Hospital, Lille
Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR)
Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction.
- Conditions
- Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
- Trial name
- TRANSLATE (NCT07455292)
- Testing
- Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement
- Where
- 2 sites in Italy
- Volunteers
- 190 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Stenosis, Severe, Aortic Stenosis
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk.
- Trial name
- HOME-TAVI (NCT07738575)
- Testing
- Same-Day Discharge Strategy, Standard-of-Care Discharge Strategy
- Where
- 3 sites in Canada, Spain
- Volunteers
- 764 people
- Sponsor
- Hospital Clinic of Barcelona
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
- Trial name
- NCT02661451
- Testing
- SAPIEN 3 THV, Optimal Heart Failure Therapy
- Where
- 51 sites in United States, Canada and 1 more
- Volunteers
- 178 people
- Sponsor
- Cardiovascular Research Foundation, New York
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.
- Trial name
- PERFECT (NCT07343674)
- Where
- 12 sites in Portugal
- Volunteers
- 500 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Aortic Valve Stenosis
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.
- Trial name
- DOUBLE-CHOICE (NCT05036018)
- Testing
- ACURATE neo2, minimalist approach, CoreValve Evolut Pro, Pro+ and FX
- Where
- 10 sites in Germany
- Volunteers
- 836 people
- Sponsor
- Leipzig Heart Science gGmbH
Aortic Stenosis, Conduction Disturbances
Systematic Ambulatory ECG Monitoring Following TAVI
This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of…
- Trial name
- RECORDII (NCT07739316)
- Testing
- Ambulatory ECG monitoring
- Where
- Canada
- Volunteers
- 754 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Stenosis
Balloon- Versus Self-Expanding Intraannular TAVI in Small Aortic Annuli
In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when…
- Trial name
- BALANCE (NCT07794306)
- Testing
- Meril Octapro+ THV System, Abbott Navitor/Navitor Vision THV system
- Where
- Germany
- Volunteers
- 510 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Valve Stenosis, Heart Failure
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events…
- Trial name
- ENAVO-TAVR (NCT05672836)
- Testing
- Enavogliflozin, Standard-of-Care
- Where
- 31 sites in South Korea
- Volunteers
- 1,040 people
- Sponsor
- Duk-Woo Park, MD
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical…
- Trial name
- ROARING-TAVI (NCT06679517)
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- University Hospital of Ferrara
Severe Aortic Valve Stenosis, Cardiovascular Diseases
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential…
- Trial name
- IMPROVE (NCT07456280)
- Testing
- Standard care, PhysioMem PM 100 4G ambulatory monitoring system
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Severe Aortic Stenosis
Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)
This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis.
- Trial name
- PURETAVI (NCT06898086)
- Testing
- Transcatheter aortic valve implantation
- Where
- 23 sites in Austria, Czechia and 5 more
- Volunteers
- 620 people
- Sponsor
- Rede Optimus Hospitalar SA
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