Atrial FibrillationNCT00486915
Impact of Left Atrial Appendage Exclusion on Short-Term Clinical Outcomes and Long-Term Stroke Incidence
A study testing Left Atrial Appendage Ligation in people with Atrial Fibrillation and Thromboembolism, run by London Health Sciences Centre at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Thromboembolism, Cerebrovascular Accident
- What is being tested?
- Left Atrial Appendage Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing mitral valve repair or replacement surgery
Who cannot join
- Patients undergoing concurrent surgical anti-arrythmia procedure
- Heart transplant patients
- Patients with known hematologic hypercoagulability disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Prophylactic Left Atrial Appendage Exclusion: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Left Atrial Appendage Ligation
- Keywords
- Atrial Fibrillation, Left Atrial Appendage, Surgical Ligation, Thromboembolism, Cerebrovascular Accident
- Medical subject headings
- Atrial Fibrillation, Thromboembolism, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage LigationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Left Atrial Appendage Exclusion | Active comparator | Not described Receives: Procedure: Left Atrial Appendage Ligation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Stroke
Measured: 4 years
Secondary outcomes (2)
Short- and Long-term biochemical parameters
Measured: 1 and 5 years
Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele
- Responsible party
- Principal investigator, Dave Nagpal, London Health Sciences Centre
- Investigators
- Dave Nagpal, MD, Principal investigator, London Health Sciences CentreLucia Torracca, MD, Principal investigator, Hospital San RafaelOttavio Alfieri, MD, Study director, Hospital San Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486915
- Sponsor's protocol ID
- HSR2007-1
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2007
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Prophylactic Left Atrial Appendage Exclusion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00486915
- Acronym / sponsor ID
- HSR2007-1
- Keywords
- Atrial Fibrillation, Left Atrial Appendage, Surgical Ligation, Thromboembolism, Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Atrial Appendage Exclusion | Active comparator | Procedure: Left Atrial Appendage Ligation |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing mitral valve repair or replacement surgery
Key exclusion criteria (3 listed)
- Patients undergoing concurrent surgical anti-arrythmia procedure
- Heart transplant patients
- Patients with known hematologic hypercoagulability disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Appendage Ligation | Procedure or surgery | Left Atrial Appendage Exclusion |
Primary outcome
Incidence of Stroke
Time frame: 4 years
2 secondary outcomes
Short- and Long-term biochemical parameters
Time frame: 1 and 5 years
Short-term clinical outcomes (Procedural complications, hospital length of stay, etc)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Nagpal, MD principal investigator
London Health Sciences Centre
Lucia Torracca, MD principal investigator
Hospital San Rafael
Ottavio Alfieri, MD study director
Hospital San Rafael
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Appendage Ligation in people with Atrial Fibrillation and Thromboembolism, run by London Health Sciences Centre at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Stroke (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.