PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
NCT ID: NCT02895737
Last Updated: 2021-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
328 participants
INTERVENTIONAL
2016-12-28
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
NCT04149535
Cerebral Protection in Transcatheter Aortic Valve Replacement
NCT02214277
The PROTEMBO Trial
NCT05873816
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
NCT04843072
The PROTEMBO SF Trial
NCT03325283
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
balloon-expandable TAVI without cerebral protection
Patient receives a balloon-expandable transcatheter aortic valve replacement without cerebral protection
TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra
balloon-expandable TAVI with cerebral protection
Patient receives a balloon-expandable transcatheter aortic valve replacement with cerebral protection
TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems
self-expandable TAVI without cerebral protection
Patient receives a self-expandable transcatheter aortic valve replacement without cerebral protection
TAVI: CoreValve® Evolut R™, CoreValve Medtronic
self-expandable TAVI with cerebral protection
Patient receives a self-expandable transcatheter aortic valve replacement with cerebral protection
TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra
TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems
TAVI: CoreValve® Evolut R™, CoreValve Medtronic
TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Freedom of significant stenosis in the area of Truncus brachiocephalicus and left A. carotis (CT)
* Necessary vessel diameter of 6.5-10 mm in the area of A. carotis communis sinistra and 9-15 mm in the area of Truncus brachiocephalicus (for delivery of protection system)
* Anomalies of aortic arch ("bovine arch" variants):
1. Direct outflow of left A. carotis communis out of Truncus brachiocephalicus
2. Conjoint origin of Truncus brachiocephalicus and left A. carotis communis out of aortic arch
* The patient has provided written informed consent
Exclusion Criteria
* Severe carotid stenosis (\>70%)
* Symptomatic or asymptomatic carotid stenosis with necessity of TEA or stenting
* Relevant psychiatric diseases
* Severe/ relevant visual, auditory or cognitive deficits which impede targeted anamnesis, neurologic evaluation or consenting.
* Severe neurodegenerative or progressive neuromuscular disease and state after severe craniocerebral injury with permanent neurologic sequelae and structural cerebral diseases
* Pronounced kinking/ stenosis or calcification in the area of the right A. radialis/ brachialis/ subclavia, which impede implantation of the cerebral protection system
* Significant stenosis, relevant calcifications, dissections or aneurysmatic alterations in the area of Truncus brachiocephalicus and/or A. carotis communis sinistra.
* Contraindications for MRI: among others the presence of a non-MRI-compatible pacemaker or defibrillator, metal implants in the area to be evaluated, metal fragments in the craniocerebral area, allergies, claustrophobia.
* Vessel alterations which impede among others the introduction of a 6 French sheath:
1. Inadequate perfusion in the area of the right upper extremity (pathologic Allen´s test, vessel obstructions, peripheral vascular disease)
2. Hemodialysis shunt, grafts, or arteriovenous fistulas in the area of right upper extremity
* Acute myocardial infarction ≤ 1 month prior to the planned procedure
* Every contraindication for the execution of a transfemoral TAVI
* Aortic annulus \<19 or \>29 mm
* Combined aortic vitium with predominant insufficiency.
* Severly reduced leftventricular function ≤ 20%
* Patients who are planned for a hybrid procedure (e.g. conventional operation and TAVI or simultaneous coronary intervention at coronary artery disease needing intervention) 14 days prior to the planned study procedure
* Intracardiac thrombus, hematoma, tumor or vegetations confirmed by echocardiography
* Endocarditis
* Planned concomitant procedure for atrial fibrillation (operative or via catheter ablation) during the follow up phase
* Need for emergency procedure
* Chronic drug-, medication or alcohol abuse
* Consuming disease
* Life expectancy \< 1 year
* Dialysis dependency
* Patient with legal incapacity, who is not able to understand the essence, meaning and consequences of the study
* Participation in other interventional clinical trials in the month of study start or planned participation during the participation of this study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deutsches Herzzentrum Muenchen, Klinik für Herz- und Gefäßchirurgie
Munich, Bavaria, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stephanie Voss, Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
290/16s
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.