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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by London Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ospedale San Raffaele
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00486915
First received: June 14, 2007
Last updated: June 22, 2011
Last verified: June 2011

June 14, 2007
June 22, 2011
April 2007
Not Provided
Incidence of Stroke [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT00486915 on ClinicalTrials.gov Archive Site
  • Short- and Long-term biochemical parameters
  • Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)
Same as current
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
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
Both
Not Provided
No
Contact: Andrea Fumero, MD fumero.andrea@hsr.it
Contact: Dave Nagpal, MD adnagpal@uwo.ca
Italy
 
NCT00486915
HSR2007-1
No
Not Provided
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