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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University Hospital, Essen
Sponsor:
Information provided by (Responsible Party):
Matthias Thielmann, West German Heart Center Essen
ClinicalTrials.gov Identifier:
NCT01735513
First received: November 22, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Transaortic Transcatheter Aortic Valve Implantation
Device: Intra-aortic embolic protection management system; Embol-X

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation: a Randomized-controlled Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • The detection of new morphological brain injury with new hyper-intense DW-MRI cerebral lesions on the post-treatment compared to the pretreatment MRI imaging [ Time Frame: Postoperative day 1-3 ] [ Designated as safety issue: Yes ]
    MRI of the brain is obtained at the same time as clinical exams. Scans are performed on a 1.5-T MR unit and a circular polarized head coil. The imaging protocol includes a transversal DW, single shot echo-planar sequence of the whole brain. Diffusion images are processed to generate isotopic apparent diffusion coefficient maps using dedicated software allowing for proper classification of the lesions. Transversal fluid-attenuated inversion recovery and transversal T2-weighted turbo spin-echo sequences are also performed. Slice thickness is 5mm for all sequences. Scans are read by an experienced neuroradiologist blinded to the clinical data. The presence, number, volume and location of all new focal diffusion abnormalities were recorded.


Secondary Outcome Measures:
  • Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]
    Stroke and transient ischaemic attack is defined according to the Valve Academic Research Consortium (VARC) recommendation. In case of stroke, the modified Rankin scale (mRS) is assessed to categorize the patient's level of functional independence during daily activities.


Other Outcome Measures:
  • Neurocognitive function postoperatively compared to preoperative status [ Time Frame: at baseline before treatment and at 1-3 days after treatment, at discharge and at 3 months ] [ Designated as safety issue: Yes ]
    Examinations were performed at baseline, pre-discharge and 3 months thereafter. Neurological status is assessed by a detailed clinical examination protocol. Cognitive function is evaluated using three different standardized neuropsychological tests and the Mini-Mental State Examination (MMSE).


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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"
Device: 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.
Other Name: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.
Active Comparator: 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"
Device: 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.
Other Name: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735513

Locations
Germany
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen Recruiting
Essen, Germany, 45122
Contact: Matthias Thielmann, MD, PhD       matthias.thielmann@uni-due.de   
Contact: Wolfgang Ristau    +49-201-723-84927    wolfgang.ristau@uk-essen.de   
Principal Investigator: Matthias Thielmann, MD, PhD         
Sub-Investigator: Philipp Kahlert, MD         
Sub-Investigator: Daniel Wendt, MD         
Sub-Investigator: Stephan Knipp, MD         
Sponsors and Collaborators
University Hospital, Essen
  More Information

No publications provided

Responsible Party: Matthias Thielmann, PD. Dr. med. Matthias Thielmann, West German Heart Center Essen
ClinicalTrials.gov Identifier: NCT01735513     History of Changes
Other Study ID Numbers: WDHZ-TC-TAo-EmbolX
Study First Received: November 22, 2012
Last Updated: November 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Essen:
transaortic TAVI or TAVR
embolic protection device
EmbolX
efficacy
during transaortic TAVI
reduce the incidence of new foci of restricted diffusion on diffusion-weighted MRI

ClinicalTrials.gov processed this record on July 28, 2014