A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGUARD*3 Embolic Protection Device in patients undergoing Transcatheter Aortic Valve Implantation (TAVI)

A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGUARD*3 Embolic Protection Device in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) - TriGUARD3 First in man

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46441

Enrollment

Registered

2018-05-18

Start date

2018-11-14

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preventie CVA/TIA bij TAVI paralysis Stroke

Interventions

Standard of care TAVI procedure, during the procedure the Triguard 3 protection device will be placed.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. The patient must be * 18 years of age. 2. The patient meets indications for TAVI procedure. 3. The patient 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) 4. The patient is willing to comply with specified follow-up evaluations.

Exclusion criteria

Exclusion criteria: 1.Patients undergoing TAVI via the trans-axillary, transapical, subclavian, or direct aortic route 2 Patients with impaired renal function (estimated Glomerular Filtration Rate [eGFR]

Design outcomes

Primary

Measure	Time frame
* Successful device deployment, defined as ability to access the aortic arch with the TriGUARD* 3 delivery catheter and deploy the device from the delivery catheter into the aortic arch. * Device position, defined as ability to position the TriGUARD* 3 device in the aortic arch to cover all major cerebral arteries, with proper positioning maintained (verified by angiography) until the following time points: o Final deployment of the first prosthetic valve o Final procedure (after any additional post-dilation or additional valve implantations have been completed, and the TAVI delivery system has been removed) Extent of cerebral artery coverage will be reported as: o Complete (coverage of all 3 cerebral artery branches) o Partial (coverage of 1 or 2 cerebral artery branches) o None * Device interference, defined as interaction of the TriGUARD* 3 device with the TAVI system leading to: o Inability to advance or manipulate the TAVI delivery system or valve prosthesis, OR o Inability to deploy the TAVI valve prosthesis, OR o Inability to retrieve the valve prosthesis or delivery system * Successful device retrieval, defined as ability to retrieve the TriGUARD* 3 device and remove the intact delivery system Primary Safety Endpoint Analysis Incidence of investigational device-related and investigational procedure-related serious adverse events in a composite hierarchical safety endpoint during and immediately post TAVI (before discharge from the cath lab) hierarchical safety endpoint. * Cardiovascular death * Ischemic stroke * Life-threatening or disabling bleeding (EXCLUDE TAVI SIDE RELATED) * Acute kidney injury (stage 2 or 3)	—

Measure

Time frame

* Successful device deployment, defined as ability to access the aortic arch with the TriGUARD* 3 delivery catheter and deploy the device from the delivery catheter into the aortic arch. * Device position, defined as ability to position the TriGUARD* 3 device in the aortic arch to cover all major cerebral arteries, with proper positioning maintained (verified by angiography) until the following time points: o Final deployment of the first prosthetic valve o Final procedure (after any additional post-dilation or additional valve implantations have been completed, and the TAVI delivery system has been removed) Extent of cerebral artery coverage will be reported as: o Complete (coverage of all 3 cerebral artery branches) o Partial (coverage of 1 or 2 cerebral artery branches) o None * Device interference, defined as interaction of the TriGUARD* 3 device with the TAVI system leading to: o Inability to advance or manipulate the TAVI delivery system or valve prosthesis, OR o Inability to deploy the TAVI valve prosthesis, OR o Inability to retrieve the valve prosthesis or delivery system * Successful device retrieval, defined as ability to retrieve the TriGUARD* 3 device and remove the intact delivery system Primary Safety Endpoint Analysis Incidence of investigational device-related and investigational procedure-related serious adverse events in a composite hierarchical safety endpoint during and immediately post TAVI (before discharge from the cath lab) hierarchical safety endpoint. * Cardiovascular death * Ischemic stroke * Life-threatening or disabling bleeding (EXCLUDE TAVI SIDE RELATED) * Acute kidney injury (stage 2 or 3)

—

Secondary

Measure	Time frame
* All-cause mortality * All stroke o Disabling o Non-disabling * Life threatening (or disabling) bleeding * Acute kidney injury * Stage 2 or 3 (including renal replacement therapy) * Major vascular complications MRI results 2-5 days after TAVI	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)