Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation

NCT ID: NCT01735513

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-09-30

Brief Summary

Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve implantation by the use of an embolic protection device.

Conditions

Transaortic Transcatheter Aortic Valve Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transaortic TAVI with EmbolX

Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation with the use of the embolic protection device "EmbolX"

Group Type: EXPERIMENTAL

Intra-aortic embolic protection management system; Embol-X

Intervention Type: DEVICE

The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers" which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.

Transaortic TAVI without EmbolX

Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device "EmbolX"

Group Type: ACTIVE_COMPARATOR

Intra-aortic embolic protection management system; Embol-X

Intervention Type: DEVICE

The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers" which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.

Interventions

Intra-aortic embolic protection management system; Embol-X

The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers" which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.

Intervention Type: DEVICE

Other Intervention Names

Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.

Eligibility Criteria

Inclusion Criteria

Patients with symptomatic severe aortic valve stenosis (valve area <0.8 cm2) are considered candidates for TAVI (TAVR) if they have a logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE) ≥15% or surgery is deemed to be at excessive risk because of comorbidities and other risk factors not being captured by these scoring systems. Indication for TAVI in the individual patient is discussed in a consensus conference of cardiologists and cardiac surgeons, and patient's or physician's preference alone is not considered adequate for decision making. The performance of TAVI in these patients is approved by the local authorities. All patients have to agree to participate in the study, and written informed consent is obtained.

Exclusion Criteria

Patients are excluded from TAVI (TAVR) in the presence of any of the following conditions:

• bicuspid aortic valve
• aortic annulus diameter ≤18 or ≥27 mm
• procelain aorta
• unprotected left main disease
• recent myocardial infarction or cerebrovascular event
• sepsis or active endocarditis
• severe aortic atheroma
• left ventricular or atrial thrombus
• active peptic ulcer
• bleeding diathesis
• hypersensitivity to antiplatelet therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Matthias Thielmann

PD. Dr. med. Matthias Thielmann

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen

Essen, , Germany

Countries

Germany

References

Wendt D, Kleinbongard P, Knipp S, Al-Rashid F, Gedik N, El Chilali K, Schweter S, Schlamann M, Kahlert P, Neuhauser M, Forsting M, Erbel R, Heusch G, Jakob H, Thielmann M. Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation. Ann Thorac Surg. 2015 Aug;100(2):686-91. doi: 10.1016/j.athoracsur.2015.03.119.

Reference Type: DERIVED

PMID: 26234838 (View on PubMed)

Other Identifiers

WDHZ-TC-TAo-EmbolX

Identifier Type: -

Identifier Source: org_study_id