Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable ValvesPROTECTNCT02895737
PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
A study testing TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra, TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems and TAVI: CoreValve® Evolut R™, CoreValve Medtronic in people with Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves by using a cerebral protection system (Sentinel™ Device). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves
- What is being tested?
- TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra, TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems and TAVI: CoreValve® Evolut R™, CoreValve Medtronic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteGermany
- Study dates
- 28 Dec 2016to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aortic stenosis and indication for transfemoral aortic valve replacement
- 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):
- Direct outflow of left A. carotis communis out of Truncus brachiocephalicus
- Conjoint origin of Truncus brachiocephalicus and left A. carotis communis out of aortic arch
- The patient has provided written informed consent
Who cannot join
- Apoplexy/ TIA during the last ½ year
- 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
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- 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:
- Inadequate perfusion in the area of the right upper extremity (pathologic Allen´s test, vessel obstructions, peripheral vascular disease)
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen, Klinik für Herz- und Gefäßchirurgie
Munich, Bavaria, 80636
Stephanie Voss, Dr., 00498912180
About this study
This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves by using a cerebral protection system (Sentinel™ Device).
- Being tested
- 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
- Keywords
- aortic stenosis, transcatheter aortic valve replacement, stroke, ischemic infarction, cerebral embolic protection device
- Medical subject headings
- Aortic Valve Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien UltraDevice
TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection SystemsDevice
TAVI: CoreValve® Evolut R™, CoreValve MedtronicDevice
TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection SystemsDevice
| Study group | Role | What they receive |
|---|---|---|
| balloon-expandable TAVI without cerebral protection | Other | Patient receives a balloon-expandable transcatheter aortic valve replacement without cerebral protection Receives: Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra |
| balloon-expandable TAVI with cerebral protection | Other | Patient receives a balloon-expandable transcatheter aortic valve replacement with cerebral protection Receives: Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems |
| self-expandable TAVI without cerebral protection | Other | Patient receives a self-expandable transcatheter aortic valve replacement without cerebral protection Receives: Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic |
| self-expandable TAVI with cerebral protection | Other | Patient receives a self-expandable transcatheter aortic valve replacement with cerebral protection Receives: Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI)
Measured: Day 2-4 post-procedure
Secondary outcomes (3)
Number of new cerebral lesions detected by MRI
Measured: Day 2-4 post-procedure
Occurrence of clinical stroke and/or neurocognitive dysfunction as assessed by neurological and neurocognitive assessments
Measured: Day 2-4 post-procedure; 6 months post-procedure
Postoperative Outcome according to the VARC 2 criteria
Measured: from operation until hospital discharge; 30-days, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start28 Dec 2016
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable ValvesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895737
- Sponsor's protocol ID
- 290/16s
- Acronym
- PROTECT
- Status last verified
- Jan 2021
- First submitted
- 6 Sep 2016
- Last updated
- 4 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
- ClinicalTrials.gov ID
- NCT02895737
- Acronym / sponsor ID
- PROTECT / 290/16s
- Keywords
- aortic stenosis, transcatheter aortic valve replacement, stroke, ischemic infarction, cerebral embolic protection device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 28 Dec 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves by using a cerebral protection system (Sentinel™ Device).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| balloon-expandable TAVI without cerebral protection | Other | Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien UltraPatient receives a balloon-expandable transcatheter aortic valve replacement without cerebral protection |
| balloon-expandable TAVI with cerebral protection | Other | Device: TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection SystemsPatient receives a balloon-expandable transcatheter aortic valve replacement with cerebral protection |
| self-expandable TAVI without cerebral protection | Other | Device: TAVI: CoreValve® Evolut R™, CoreValve MedtronicPatient receives a self-expandable transcatheter aortic valve replacement without cerebral protection |
| self-expandable TAVI with cerebral protection | Other | Device: TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection SystemsPatient receives a self-expandable transcatheter aortic valve replacement with cerebral protection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with aortic stenosis and indication for transfemoral aortic valve replacement
- 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):
- The patient has provided written informed consent
Key exclusion criteria (28 listed)
- Apoplexy/ TIA during the last ½ year
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra | Device | balloon-expandable TAVI without cerebral protection |
| TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems | Device | balloon-expandable TAVI with cerebral protection |
| TAVI: CoreValve® Evolut R™, CoreValve Medtronic | Device | self-expandable TAVI without cerebral protection |
| TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems | Device | self-expandable TAVI with cerebral protection |
Primary outcome
Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI)
Time frame: Day 2-4 post-procedure
3 secondary outcomes
Number of new cerebral lesions detected by MRI
Time frame: Day 2-4 post-procedure
Occurrence of clinical stroke and/or neurocognitive dysfunction as assessed by neurological and neurocognitive assessments
Time frame: Day 2-4 post-procedure; 6 months post-procedure
Postoperative Outcome according to the VARC 2 criteria
Time frame: from operation until hospital discharge; 30-days, 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra, TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems and TAVI: CoreValve® Evolut R™, CoreValve Medtronic in people with Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Voss, Dr. (0049 89 1218 0, VossS@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total new lesion volume in protected brain regions detected by Magnetic Resonance Imaging (MRI) (time frame: Day 2-4 post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.