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
  Purpose

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 Intervention
Atrial Fibrillation
Thromboembolism
Cerebrovascular Accident
Procedure: Left Atrial Appendage Ligation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Concurrent Prophylactic Left Atrial Appendage Exclusion: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

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

Secondary Outcome Measures:
  • Short- and Long-term biochemical parameters
  • Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)

Estimated Enrollment: 150
Study Start Date: April 2007
Estimated Study Completion Date: December 2011
Arms Assigned Interventions
Active Comparator: Left Atrial Appendage Exclusion Procedure: Left Atrial Appendage Ligation
No Intervention: Control

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486915

Contacts
Contact: Andrea Fumero, MD fumero.andrea@hsr.it
Contact: Dave Nagpal, MD adnagpal@uwo.ca

Locations
Italy
Hospital San Rafael Recruiting
Milan, MI, Italy
Sponsors and Collaborators
London Health Sciences Centre
Ospedale San Raffaele
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00486915     History of Changes
Other Study ID Numbers: HSR2007-1
Study First Received: June 14, 2007
Last Updated: June 22, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by London Health Sciences Centre:
Atrial Fibrillation
Left Atrial Appendage
Surgical Ligation
Thromboembolism
Cerebrovascular Accident

Additional relevant MeSH terms:
Atrial Fibrillation
Cerebral Infarction
Stroke
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Embolism and Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on April 17, 2014