Clinical trial NCT00486915: Impact of Left Atrial Appendage Exclusion on Short-Term Clinical Outcomes and Long-Term Stroke Incidence
Official title: Concurrent Prophylactic Left Atrial Appendage Exclusion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Thromboembolism
Cerebrovascular Accident
Keywords: Atrial Fibrillation
Left Atrial Appendage
Surgical Ligation
Thromboembolism
Cerebrovascular Accident
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Ospedale San Raffaele
First posted: 2007-06-15
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Incidence of Stroke
timeFrame: 4 years
Secondary outcomes:
measure: Short- and Long-term biochemical parameters
timeFrame: 1 and 5 years
measure: Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)
timeFrame: 30 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Hospital San Rafael
state: MI
Study officials:
affiliation: London Health Sciences Centre
name: Dave Nagpal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Rafael
name: Lucia Torracca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Rafael
name: Ottavio Alfieri, MD
role: STUDY_DIRECTOR
References: