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)

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) - DEFLECT II

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40150

Enrollment

Registered

2013-12-13

Start date

2014-01-09

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

brain infarction stroke

Interventions

None listed

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 is willing to comply with specified follow-up evaluations.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing TAVI via the trans-axillary, subclavian, or direct aortic route 2. 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. 3. 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 CK and CK-MB have not returned to normal limits at the time of procedure. 4. Patients who are currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain. 5. Patients with impaired renal function (estimated Glomerular Filtration Rate [eGFR] 700.000 cells/mm³ or a WBC

Design outcomes

Primary

Measure	Time frame
The primary endpoints of this trial are device performance and hierarchical composite device/investigational procedure-related safety during and immediately post TAVI procedure. Both endpoints will be evaluated in the Intention to Treat (ITT) and PP (Per Protocol) population using descriptive statistics. No formal hypothesis testing will be performed.	—

Secondary

Measure	Time frame
The secondary endpoint analysis of the number and volume of new cerebral lesions by diffusion-weighted MRI at 4+2 days (range 2-6 days) will be evaluated in the PP population.	—

Countries

Netherlands

Outcome results