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

NCT ID: NCT00486915

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2012-12-31

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.

Conditions

Atrial Fibrillation; Thromboembolism; Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Left Atrial Appendage Exclusion

Group Type: ACTIVE_COMPARATOR

Left Atrial Appendage Ligation

Intervention Type: PROCEDURE

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Left Atrial Appendage Ligation

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Raffaele

OTHER

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dave Nagpal

Associate Professor of Cardiac Surgery and Critical Care Medicine, Surgical Director of Heart Failure and Mechanical Circulatory Support Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dave Nagpal, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Lucia Torracca, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Rafael

Ottavio Alfieri, MD

Role: STUDY_DIRECTOR

Hospital San Rafael

Locations

Hospital San Rafael

Milan, MI, Italy

Countries

Italy

Other Identifiers

HSR2007-1

Identifier Type: -

Identifier Source: org_study_id