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I Can sEe Left Atrial Appendage (ICELAA) Clinical Study (ICELAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04196335
Recruitment Status : Not yet recruiting
First Posted : December 12, 2019
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.

Condition or disease Intervention/treatment Phase
Efficacy, Self Safety Issues Device: intra-procedural intracardiac echocardiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: I Can sEe Left Atrial Appendage (ICELAA) Clinical Study
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: single-arm Device: intra-procedural intracardiac echocardiography
use of intra-procedural intracardiac echocardiography during Watchman FLX devices
Other Name: Watchman FLX Device




Primary Outcome Measures :
  1. Significant leak (>5 mm) as assessed by TEE at 45 days' post-implant. [ Time Frame: 45 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject is of legal age to participate in the study per the laws of their respective geography;
  2. The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject does not have mitral stenosis or a mechanical heart valve);the subject has not been diagnosed with rheumatic mitral valvular heart disease);
  3. The subject is deemed by the treating physician to be suitable for the protocol defined pharmacologic regimens;
  4. The subject has a calculated CHA2DS2-VASc score of 2 or greater;
  5. The subject is able to undergo ICE examinations;The subject is able to undergo ICE(which will be used during the index procedure) and TEE (which will be performed at 45 days and may also be performed at baseline);
  6. The subject is able to understand and willing to provide written informed consent to participate in the trial;
  7. The subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

  1. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed;
  2. The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoaguable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic warfarin therapy);
  3. The subject has a history of atrial septal repair or has an ASD/PFO device;
  4. The subject has an implanted mechanical valve prosthesis in any position;
  5. The subject currently or has had any documented history of, New York Heart Association Class IV Congestive Heart Failure;
  6. The subject is of childbearing potential and is or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196335


Contacts
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Contact: Valerie Lens +32491153990 valerie.Lens@bsci.com

Locations
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Denmark
Aarhus Universitetshospital
Skejby, Denmark
France
CHU Dijon
Dijon, France
Bordeaux University Hospital/Hôpital Middle Haut Lévêque
Pessac, France
Italy
Fondazione Toscana Gabriele Monasterio
Massa, Italy
Centro Cardiologico Fondazione Monzino
Milan, Italy
Spain
Hospital de Sant Pau
Barcelona, Spain
United Kingdom
John Radcliffe
Oxford, United Kingdom
Sponsors and Collaborators
Boston Scientific Corporation
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04196335    
Other Study ID Numbers: S2459
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No