Aortic Valve StenosisTAVINCT02070731
DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI
A study testing TriGuard HDH in people with Aortic Valve Stenosis, run by Keystone Heart at 14 sites in 6 countries.
Trial summary
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation. 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
- 86 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Feb 2014to Apr 2015
- 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 is a male or non-pregnant female ≥18 years of age
- Patient meets indications for TAVI
- The patient is willing to comply with protocol-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 provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB)
Who cannot join
- Patients undergoing TAVI via the trans-axillary, trans-subclavian, or trans-aortic route
- Patients undergoing TAVI via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
- 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, in whom creatine kinase and creatine kinase-Muscle Brain have not returned to within 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 a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
Show all 22Show fewer
- Patients with known other mental or physical 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 severe allergy to heparin or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, 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 history of upper gastrointestinal (GI) bleeding within the prior 6 months
- Patients with renal failure (estimated Glomerular Filtration Rate [estimated Glomerular Filtration Rate] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
- Patients with hepatic failure (Child-Pugh class C)
- Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
- Patients presenting with cardiogenic shock or severe hypotension (systolic blood pressure <90 mm Hg) at the time of the index procedure
- Patients with severe peripheral arterial disease that precludes delivery sheath vascular access
- Patients with a heavily calcified or severely atheromatous aortic arch
- Patients with an innominate artery ostium diameter <11 mm
- Patients with a transverse aortic diameter >40 mm
- Patients with anatomic irregularities of the aortic arch or innominate artery that could prevent positioning and stability of the device
- Patients with contraindication to cerebral MRI
- Patients who have a planned treatment with any other investigational device or procedure during the study period
- Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVI procedure or within two (2) weeks prior to the TAVI procedure.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Germany4 sites
Praxisklinik Herz Und Gefässe
Dresden
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau
Medical Care Center
Hamburg
Städtische Kliniken Neuss
Neuss
France3 sites
Hôpital de la Cavale Blanche
Brest
Chru-Lille
Lille, 59000
Clinique chez APHM
Marseille
United Kingdom3 sites
Royal Sussex County Hospital
Brighton
Bristol Heart Institute
Bristol
Leeds General Infirmary
Leeds
About this study
Official title: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During Transcatheter Aortic Valve Implantation
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.
Read the detailed description
The TriGuard HDH device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation.
To assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI.
Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms:
- Intervention - TAVI with the TriGuard HDH embolic deflection device
- Control - standard unprotected TAVI
- Conditions
- Aortic Valve Stenosis
- Being tested
- TriGuard HDH
- Keywords
- TAVR, TAVI, Aortic Valve Stenosis
- 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
Also called TriGuard HDH embolic deflection device
TAVI with the TriGuard HDH embolic deflection device
| Study group | Role | What they receive |
|---|---|---|
| unprotected TAVI | No intervention | standard unprotected Transcatheter Aortic Valve Implantation |
| TAVI with the TriGuard HDH | Experimental | TAVI with the TriGuard HDH embolic deflection device Receives: Device: TriGuard HDH |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital procedural safety
In-hospital procedural safety, defined as the composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE):
- All-cause mortality
- All stroke (disabling and non-disabling)
- Life threatening (or disabling) bleeding
- Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)
- Major vascular complications
Measured: Up to 7 days during post procedure hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionApr 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keystone Heart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Baumbach, Md., Principal investigator, Bristol Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070731
- Sponsor's protocol ID
- DEFLECT III
- Acronym
- TAVI
- Status last verified
- Aug 2015
- First submitted
- 20 Feb 2014
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT02070731
- Acronym / sponsor ID
- TAVI / DEFLECT III
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVR, TAVI, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Keystone HeartIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 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.
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.
Detailed description
The TriGuard HDH device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation.
To assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI.
Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms:
- Intervention - TAVI with the TriGuard HDH embolic deflection device
- Control - standard unprotected TAVI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unprotected TAVI | No intervention | –standard unprotected Transcatheter Aortic Valve Implantation |
| TAVI with the TriGuard HDH | Experimental | Device: TriGuard HDHTAVI with the TriGuard HDH embolic deflection device |
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 is a male or non-pregnant female ≥18 years of age
- Patient meets indications for TAVI
- The patient is willing to comply with protocol-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 provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB)
Key exclusion criteria (22 listed)
- Patients undergoing TAVI via the trans-axillary, trans-subclavian, or trans-aortic route
- Patients undergoing TAVI via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
- 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, in whom creatine kinase and creatine kinase-Muscle Brain have not returned to within 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
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 HDHAlso: TriGuard HDH embolic deflection deviceTAVI with the TriGuard HDH embolic deflection device | Device | TAVI with the TriGuard HDH |
Primary outcome
In hospital procedural safety
Time frame: Up to 7 days during post procedure hospitalization
In-hospital procedural safety, defined as the composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE): * All-cause mortality * All stroke (disabling and non-disabling) * Life threatening (or disabling) bleeding * Acute kidney injury - Stage 2 or 3 (including renal replacement therapy) * Major vascular complications
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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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Andreas Baumbach, Md. principal investigator
Bristol Heart Institute
14 sites in 6 countries: 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 14 sites in 6 countries.
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 22 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 14 sites in Germany, France, United Kingdom, Israel, Italy and 1 more country. 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?
In hospital procedural safety (time frame: Up to 7 days during post procedure hospitalization). 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.