Aortic Valve StenosisNCT02073851
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
A study testing TriGuard™HDH in people with Aortic Valve Stenosis, run by Keystone Heart at 1 site in Netherlands.
Trial summary
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- TriGuard™HDH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Sep 2014
- 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
- The patient must be ≥ 18 years of age.
- The patient meets indications for transcatheter aortic valve replacement procedure.
- The patient is willing to comply with specified follow-up evaluations.
- The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (EC).
Who cannot join
- Patients undergoing transcatheter aortic valve replacement via the trans-axillary, subclavian, or direct aortic route
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
- Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI > 72 hours preceding the index procedure and creatine kinase and creatine kinase fraction have not returned to normal limits at the time of procedure.
- Patients who are currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain.
- Patients with impaired renal function (estimated Glomerular Filtration Rate [Estimated Glomerular Filtration Rate] <30, calculated from serum creatinine by the Cockcroft-Gault formula).
- Patients with torturous/unsuitable anatomy as related to major cerebral arteries in the aortic arch that may interfere with device deployment or remain deployed.
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- Patients with a platelet count <100.000 cells/mm³ or >700.000 cells/mm³ or a white blood cell <3000 cells/mm³ within 7 days prior to index procedure.
- Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or will refuse transfusion.
- Patients who have received any organ transplant or are on a waiting list for any organ transplant.
- Poor fluoroscopic visualization due to obesity or other medical reason
- Hypotension requiring iv/ia medication or other therapy such as resuscitation and defibrillation
- Patients with known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year.
- Patients with a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, latex, and/or contrast sensitivity that cannot be adequately pre-medicated.
- Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
- Patients with an active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- Patients presenting with cardiogenic shock.
- Patients with severe peripheral arterial disease that precludes the delivery sheath vascular access.
- Patients with severe calcification/atheroma, friable or mobile atherosclerotic plaque in the aortic arch
- Patients with contraindication to cerebral MRI.
- Patients going through unprotected (cerebral embolization) cardiovascular procedure prior, during or post transcatheter aortic valve replacement procedure, before the post-procedure diffusion-weighted magnetic resonance imaging evaluation
- Patients who have a planned treatment with any other investigational device or procedure during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Arm Feasibility Pilot Study to Evaluate the Safety and Performance of the TriGuard™HDH Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
Read the detailed description
Prospective, single center, single arm pilot study enrolling up to 12 patients at a single investigational site in the netherlands. Patients meeting eligibility criteria for TAVR and none of the exclusion criteria will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
- Conditions
- Aortic Valve Stenosis
- Being tested
- TriGuard™HDH
- Keywords
- TAVR
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriGuard™HDHDevice
TriGuard™HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)
| Study group | Role | What they receive |
|---|---|---|
| TriGuard™HDH | Experimental | Patients undergoing TAVR will be treated wIth experimental device TriGuard™HDH Receives: Device: TriGuard™HDH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device performance
Device performance will be evaluated for the following functions: Access the aortic arch, Deploy the TriGuard™HDH from the delivery catheter, Position the TriGuard™HDH to cover the cerebral/carotid vessels, Retrieve the TriGuard™HDH system intact
Measured: During TAVR procedure
Secondary outcomes (2)
Number of new cerebral lesions
The number of new cerebral lesions by diffusion-weighted MRI one week post procedure
Measured: one week post procedure
Volume of new cerebral lesions
The volume of new cerebral lesions by diffusion weighted MRI one week post procedure
Measured: One week post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keystone Heart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pieter Stella, Md., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073851
- Sponsor's protocol ID
- DEFLECT II
- Status last verified
- Aug 2015
- First submitted
- 27 Jan 2014
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm Feasibility Pilot Study to Evaluate the Safety and Performance of the TriGuard™HDH Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
- ClinicalTrials.gov ID
- NCT02073851
- Acronym / sponsor ID
- DEFLECT II
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Keystone HeartIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Feb 2014 (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.
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
Detailed description
Prospective, single center, single arm pilot study enrolling up to 12 patients at a single investigational site in the netherlands. Patients meeting eligibility criteria for TAVR and none of the exclusion criteria will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TriGuard™HDH | Experimental | Device: TriGuard™HDHPatients undergoing TAVR will be treated wIth experimental device TriGuard™HDH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be ≥ 18 years of age.
- The patient meets indications for transcatheter aortic valve replacement procedure.
- The patient is willing to comply with specified follow-up evaluations.
- The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (EC).
Key exclusion criteria (21 listed)
- Patients undergoing transcatheter aortic valve replacement via the trans-axillary, subclavian, or direct aortic route
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
- Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI > 72 hours preceding the index procedure and creatine kinase and creatine kinase fraction have not returned to normal limits at the time of procedure.
- Patients who are currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain.
- Patients with impaired renal function (estimated Glomerular Filtration Rate [Estimated Glomerular Filtration Rate] <30, calculated from serum creatinine by the Cockcroft-Gault formula).
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 |
|---|---|---|
| TriGuard™HDHTriGuard™HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR) | Device | TriGuard™HDH |
Primary outcome
Device performance
Time frame: During TAVR procedure
Device performance will be evaluated for the following functions: Access the aortic arch, Deploy the TriGuard™HDH from the delivery catheter, Position the TriGuard™HDH to cover the cerebral/carotid vessels, Retrieve the TriGuard™HDH system intact
2 secondary outcomes
Number of new cerebral lesions
Time frame: one week post procedure
Volume of new cerebral lesions
Time frame: One week post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
Related trials for Aortic Valve Stenosis
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Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
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Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Pieter Stella, Md. principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriGuard™HDH in people with Aortic Valve Stenosis, run by Keystone Heart at 1 site in Netherlands.
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 4 inclusion and 21 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: finished, as of the sponsor's last update on 27 Aug 2015. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device performance (time frame: During TAVR 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 27 Aug 2015; AzTrials last refreshed its copy on 29 Oct 2026.