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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 : Completed
First Posted : June 15, 2007
Last Update Posted : August 15, 2019
Ospedale San Raffaele
Information provided by (Responsible Party):
Dave Nagpal, London Health Sciences Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Thromboembolism Cerebrovascular Accident Procedure: Left Atrial Appendage Ligation Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Concurrent Prophylactic Left Atrial Appendage Exclusion: A Randomized Controlled Trial
Study Start Date : April 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Left Atrial Appendage Exclusion Procedure: Left Atrial Appendage Ligation
No Intervention: Control

Primary Outcome Measures :
  1. Incidence of Stroke [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Short- and Long-term biochemical parameters [ Time Frame: 1 and 5 years ]
  2. Short-term clinical outcomes (Procedural complications, hospital length of stay, etc) [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00486915

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Hospital San Rafael
Milan, MI, Italy
Sponsors and Collaborators
London Health Sciences Centre
Ospedale San Raffaele
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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

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Responsible Party: Dave Nagpal, Associate Professor of Cardiac Surgery and Critical Care Medicine, Surgical Director of Heart Failure and Mechanical Circulatory Support Program, London Health Sciences Centre Identifier: NCT00486915     History of Changes
Other Study ID Numbers: HSR2007-1
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Keywords provided by Dave Nagpal, London Health Sciences Centre:
Atrial Fibrillation
Left Atrial Appendage
Surgical Ligation
Cerebrovascular Accident
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases