Aortic StenosisNCT01448421

DEFLECT I: Keystone Heart Embolic Deflection Trial

A study testing Keystone Heart Embolic Deflection Device in people with Aortic Stenosis, run by Keystone Heart.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR). The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Aortic Stenosis
What is being tested?: Keystone Heart Embolic Deflection Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: No sites listed yet
Study dates: Mar 2012to Jan 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient must be ≥18 years of age.
Patient meets indications for TAVR procedure.
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 or Institutional Review Board.

Who cannot join

Patients undergoing TAVR 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, in whom creatine kinase and creatine kinase 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 impaired renal function (estimated Glomerular Filtration Rate [estimated Glomerular Filtration Rate] <30, calculated from serum creatinine by the Cockcroft-Gault formula)
Patients with a platelet count of <100.000 cells/mm³ or > 700.000 cells/mm³ or a white blood cell < 3000 cells/mm³ within 7 days prior to index procedure.

Show all 17Show fewer

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.
Patients who have received any organ transplant or are on a waiting list for any organ transplant.
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 known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, 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 presenting with cardiogenic shock.
Patients with severe peripheral arterial disease that precludes 9 French sheath vascular access.
Patients with documented friable or mobile atherosclerotic plaque in the aortic arch.
Patients with contraindication to cerebral MRI.
Patients who have a planned treatment with any other investigational device or procedure during the study period

About this study

Official title: A Prospective, Single Arm Feasibility Study to Evaluate the Safety and Performance of the Keystone Heart Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)

The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve. The new valve is put into place using a long, thin tube called a catheter that is inserted into a small incision (cut) in the patient's groin and threaded through his/her arteries up to the heart.

Read the detailed description

During the TAVR procedure, there is a risk that an abnormal particle (called embolism) could break off from inside the arteries and travel to the brain. The embolism could be made of clumps of blood (clots), air, part of your body tissue, or part of a medical device. If the embolism is carried through the blood to the brain, it could cause a stroke or other neurological (brain) problems. A stroke happens when blood flow to a part of the brain is blocked, causing brain cells to die.

The Keystone Heart Embolic Deflection Device has been developed to prevent an embolism from going to the brain and causing a stroke or other brain damage. The device is a wire mesh filter that covers the vessels that carry blood to brain, deflecting any any blood clots or other materials away from the patient's brain and towards the lower body, where they are less likely to cause harm.

Conditions: Aortic Stenosis
Being tested: Keystone Heart Embolic Deflection Device
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.

Keystone Heart Embolic Deflection DeviceDevice
The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.

Study groups in NCT01448421
Study group	Role	What they receive
Keystone Heart Embolic Deflection Device	Experimental	Protected Transcatheter Aortic Valve Replacement Receives: Device: Keystone Heart Embolic Deflection Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Where the Device Accessed, Deployed and Was Positioned in the Aortic Arch (Device Performance)
Device ability to access and deploy in the aortic arch and position the device to cover all three vessels.
Measured: During the procedure
Number of Serious Adverse Events Related to Investigational Device and Procedure
Incidence of investigational device- and investigational procedure-related serious adverse events
Measured: 30 days follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jan 2014

First posted7 Oct 2011 (estimated)
Study startMar 2012
Primary completionJun 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aortic 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: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01448421
Sponsor's protocol ID: DEFLECT I
Status last verified: Jan 2014
First submitted: 20 Sep 2011
Last updated: 14 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention. 2015 May;11(1):75-84. doi: 10.4244/EIJY15M04_01.
PubMed 25868876

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single Arm Feasibility Study to Evaluate the Safety and Performance of the Keystone Heart Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
ClinicalTrials.gov ID: NCT01448421
Acronym / sponsor ID: DEFLECT I
Conditions: Aortic Stenosis
Keywords: TAVR
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Keystone HeartIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Jun 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 7 Oct 2011 (estimated)
Results: Posted 14 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Keystone Heart Embolic Deflection Device	Experimental	Device: Keystone Heart Embolic Deflection DeviceProtected Transcatheter Aortic Valve Replacement

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

The patient must be ≥18 years of age.
Patient meets indications for TAVR procedure.
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 or Institutional Review Board.

Key exclusion criteria (17 listed)

Patients undergoing TAVR 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, in whom creatine kinase and creatine kinase 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 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
Keystone Heart Embolic Deflection DeviceThe Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.	Device	Keystone Heart Embolic Deflection Device

Primary outcome

Number of Patients Where the Device Accessed, Deployed and Was Positioned in the Aortic Arch (Device Performance)
Time frame: During the procedure
Device ability to access and deploy in the aortic arch and position the device to cover all three vessels.
Number of Serious Adverse Events Related to Investigational Device and Procedure
Time frame: 30 days follow-up
Incidence of investigational device- and investigational procedure-related serious adverse events

Results and safety

Results posted to the registry on 14 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Keystone Heart Embolic Deflection Device	37	37

Primary outcome: Number of Patients Where the Device Accessed, Deployed and Was Positioned in the Aortic Arch (Device Performance)

Time frame: During the procedure. Count of participants. Unit: Participants

Measure	Keystone Heart Embolic Deflection Device n = 37
Value	33

Primary outcome: Number of Serious Adverse Events Related to Investigational Device and Procedure

Time frame: 30 days follow-up. Number. Unit: serious adverse events

Measure	Keystone Heart Embolic Deflection Device n = 37
Value	0

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Keystone Heart Embolic Deflection Device	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25868876Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention. 2015 May;11(1):75-84. doi: 10.4244/EIJY15M04_01.

Related trials for Aortic Stenosis

Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
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.

Michael Mullen, Md. principal investigator

The Heart Hospital, London, UK

Questions about this trial

What is this clinical trial studying?

A study testing Keystone Heart Embolic Deflection Device in people with Aortic Stenosis, run by Keystone Heart.

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 17 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 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Where the Device Accessed, Deployed and Was Positioned in the Aortic Arch (Device Performance) (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01448421, which also lists 1 linked publication.

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 14 Sep 2020; AzTrials last refreshed its copy on 29 Oct 2026.