Impact of Left Atrial Appendage Exclusion on Short-Term Clinical Outcomes and Long-Term Stroke Incidence

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. Read our disclaimer for details. Identifier: NCT00486915
Recruitment Status : Unknown
Verified June 2011 by London Health Sciences Centre.
Recruitment status was:  Recruiting
First Posted : June 15, 2007
Last Update Posted : June 23, 2011
Ospedale San Raffaele
Information provided by:
London Health Sciences Centre

June 14, 2007
June 15, 2007
June 23, 2011
April 2007
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Incidence of Stroke [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT00486915 on Archive Site
  • Short- and Long-term biochemical parameters
  • Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)
Same as current
Not Provided
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Impact of Left Atrial Appendage Exclusion on Short-Term Clinical Outcomes and Long-Term Stroke Incidence
Concurrent Prophylactic Left Atrial Appendage Exclusion: A Randomized Controlled Trial
Stroke is a major cause of morbidity in western society, and an infrequent complication of cardiac surgery. The majority of thromboembolic strokes arise from the left atrium, in particular the left atrial appendage. This study aims to assess the short-term effects of left atrial appendage ligation in terms of postoperative clinical and biochemical parameters; and the long-term effects of left atrial appendage ligation in terms of stroke incidence.

In patients with non-rheumatic atrial fibrillation, the left atrial appendage is the origin of at least 90% of all left atrial clots, and the resulting systemic emboli cause approximately 25% of all strokes. The stroke rate in patients with atrial fibrillation older than 75 years of age is 8.1% per year with one clinical risk factor and is 12% per year at any age in clinical trial populations with a history of prior thromboembolism. Three-year stroke rates in elderly nursing home patients not anticoagulated are in excess of 50% (Atrial Fibrillation Investigators 1994). Anticoagulation is oftentimes withheld due to the perception of excessive risk in case of a fall; even when anticoagulation is prescribed, it is well known that therapeutic levels are not always maintained.

Left atrial appendage obliteration is commonly performed in a variety of cardiac surgical operations. There have been animal studies and theoretical arguments which demonstrate the importance of the atrial appendage in its role to support cardiac output and blood pressure, and modulate thirst and hypercoagulability (Stollberger 2003); however this has been poorly studied and documented in humans in the available literature. BNP and ANP have been shown to increase proportionately with left atrial appendage dysfunction, as have von Willebrands Factor, D-Dimer, and thrombin-antithrombin III complex (Igarashi 2001).

To date, there is not a single randomized controlled trial with adequate follow-up to assess the short- and long-term clinical effectiveness of concurrent prophylactic LAA ligation. This trial will fill that void.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Thromboembolism
  • Cerebrovascular Accident
Procedure: Left Atrial Appendage Ligation
  • Active Comparator: Left Atrial Appendage Exclusion
    Intervention: Procedure: Left Atrial Appendage Ligation
  • No Intervention: Control
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2011
Not Provided

Inclusion Criteria:

  • Patients undergoing mitral valve repair or replacement surgery

Exclusion Criteria:

  • Patients undergoing concurrent surgical anti-arrythmia procedure
  • Heart transplant patients
  • Patients with known hematologic hypercoagulability disorder
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Not Provided
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London Health Sciences Centre
Ospedale San Raffaele
Principal Investigator: Dave Nagpal, MD London Health Sciences Centre
Principal Investigator: Lucia Torracca, MD Hospital San Rafael
Study Director: Ottavio Alfieri, MD Hospital San Rafael
London Health Sciences Centre
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP