Clinical trials: Transcatheter Valve Replacement
Paravalvular Leak, Transcatheter Valve Replacement
Paravalvular Leak for Transcatheter Valve Replacement
The study objective is to assess the agreement between cMRI PVL grading (based on regurgitant fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to the circumference of the annulus).
- Trial name
- PVL-TAVR (NCT02079129)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Baylor Research Institute
Transcatheter Aortic Valve Replacement
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).
- Trial name
- GALILEO (NCT02556203)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA), Clopidogrel
- Where
- 140 sites in United States, Austria and 15 more
- Volunteers
- 1,653 people
- Sponsor
- Bayer
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Evaluation of Cerebral Thrombembolism After TAVR
EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Intracranial Embolism
- Trial name
- EARTH - TAVR (NCT02758964)
- Testing
- MRI, neurocognitive Testing
- Where
- 2 sites in Germany
- Volunteers
- 55 people
- Sponsor
- Charite University, Berlin, Germany
Transcatheter Aortic Valve Replacement
Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural).
- Trial name
- BIO TAVI (NCT02812953)
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Action, France
Severe Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Platelet Reactivity After TAVI: A Multicenter Pilot Study
A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation…
- Conditions
- Severe Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
- Trial name
- REAC-TAVI (NCT02224066)
- Testing
- Ticagrelor 90 mg twice per day during three months following TAVI, Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
- Where
- 7 sites in Spain
- Volunteers
- 65 people
- Sponsor
- Hospital de Meixoeiro
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Cardiovascular Disease, Aortic Valve Stenosis
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.
- Conditions
- Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments, Valve Surgery
- Trial name
- CAVIAR (NCT02971020)
- Testing
- Observational/Cognitive Assessment
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Minnesota Veterans Medical Research and Education Foundation
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR).
- Conditions
- Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
- Trial name
- BRAVO 2/3 (NCT01651780)
- Testing
- Bivalirudin, Unfractionated Heparin
- Where
- 33 sites in Canada, France and 5 more
- Volunteers
- 803 people
- Sponsor
- The Medicines Company
Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial
The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will…
- Trial name
- TAVR-PT (NCT02723422)
- Testing
- Prehabilitation visit/increased physical therapy post-TAVR, Standard of Care Arm
- Sponsor
- NYU Langone Health
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI
TAVI is increasingly adopted as standard treatment for many subgroups of patients with aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance regarding the optimum periinterventional drug regimen.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Intracranial Embolism
- Trial name
- DAPT-TAVI (NCT03001960)
- Testing
- Preloading before TAVI, Postloading after TAVI
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Aortic Valve Stenosis, Aortic Valve Insufficiency
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve
The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a prospective Italian registry including several centers performing TAVI, collecting baseline, procedural and outcome data.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement
- Trial name
- NCT02713932
- Testing
- Transcatheter aortic valve implantation
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Left Bundle Branch Block, Transcatheter Aortic Valve Replacement
HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients
TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers that differ considerably between devices.
- Conditions
- Left Bundle Branch Block, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
- Trial name
- HESITATE (NCT02659137)
- Testing
- HV measurement
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Transcatheter Aortic Valve Replacement
Exercise Training After Transcatheter Aortic Valve Implantation
This pilot study will evaluate the effect of a rehabilitative exercise training on exercise capacity in patients after percutaneous aortic valve replacement.
- Trial name
- SPORT:TAVI (NCT01935297)
- Testing
- Exercise
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Technical University of Munich