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

Primary Purpose

Atrial Fibrillation, Thromboembolism, Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Left Atrial Appendage Ligation
Sponsored by
London Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Left Atrial Appendage, Surgical Ligation, Thromboembolism, Cerebrovascular Accident

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital San Rafael

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Left Atrial Appendage Exclusion

Control

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Stroke

Secondary Outcome Measures

Short- and Long-term biochemical parameters
Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)

Full Information

First Posted
June 14, 2007
Last Updated
August 13, 2019
Sponsor
London Health Sciences Centre
Collaborators
Ospedale San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT00486915
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London Health Sciences Centre
Collaborators
Ospedale San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Thromboembolism, Cerebrovascular Accident
Keywords
Atrial Fibrillation, Left Atrial Appendage, Surgical Ligation, Thromboembolism, Cerebrovascular Accident

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left Atrial Appendage Exclusion
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Left Atrial Appendage Ligation
Primary Outcome Measure Information:
Title
Incidence of Stroke
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Short- and Long-term biochemical parameters
Time Frame
1 and 5 years
Title
Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Nagpal, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucia Torracca, MD
Organizational Affiliation
Hospital San Rafael
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ottavio Alfieri, MD
Organizational Affiliation
Hospital San Rafael
Official's Role
Study Director
Facility Information:
Facility Name
Hospital San Rafael
City
Milan
State/Province
MI
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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