The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical closure of LAA in patients undergoing aortic valve replacement
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- A composite of stroke, systemic embolism and cardiovascular mortality at 5
years
Secondary outcome
- Net adverse events (primary endpoint and major bleeding)
- Cardiovascular mortality
- Stroke
- Hospitalization for decompensated heart failure
- Major bleeding (BARC 3a, b, c or 5)
- Any bleeding (BARC 1, 2 3a, b, c or 5)
- Surgery related bleeding (BARC 4)
Background summary
Stroke is a relatively frequent long-term adverse event affecting up to 7-12%
of patients at 5 years follow-up in patients undergoing aortic valve
replacement surgery. In general population approximately every sixth stroke is
due to atrial fibrillation (AF). Although the incidence and prevalence of AF
are generally unknown in patients with operated aortic valve
stenosis/regurgitation, high stroke risk may be an indicator of high AF burden.
Previous studies have concluded that *90% of left atrial thrombi are located in
the left atrial appendage (LAA). Therefore LAA closure could be an alternative
strategy for prevention of ischemic stroke. Current European Association of
Cardiothoracic Surgery (EACTS) guidelines conclude that there is no proven
benefit of surgical LAA exclusion in terms of stroke reduction or mortality
benefit. The efficacy and safety of surgical closure of LAA have not been
assessed in a large scale randomized clinical trial.
Study objective
The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and
safety of surgical closure of LAA in patients undergoing aortic valve
replacement
Study design
Randomized, prospective, open-label international multicenter trial
Intervention
Investigational treatment: Surgical closure of left atrial appendage + standard
aortic valve replacement with bioprosthesis according to clinical indication
Comparative treatment: Standard aortic valve replacement with bioprosthesis
according to clinical indication
Study burden and risks
Risks: The additional risk of the LAA-closure is negligible.
Burden: Patients will be contacted by phone approximately 1, 3 and 5 years
after surgery. At 12 months patients will be requested to fill out a
questionnaire to assess quality of life.
Koekoekslaan 1
Nieuwegein 3435 cm
NL
Koekoekslaan 1
Nieuwegein 3435 cm
NL
Listed location countries
Age
Inclusion criteria
- Patients undergoing aortic valve replacement (+/- coronary bypass AND/OR
mitral valve surgery)
- Age *18 years
- No indication for long term anticoagulation at the time of enrollment.
- Patients with CHA2DS2-VASC score *2
- Patient or legally authorized representative has been informed of the nature
of the study, agrees to its provisions and has been provided written informed
consent, approved by the appropriate Medical Ethics committee or Institutional
Review Board.
Exclusion criteria
- Age < 18 years
- Expected survival < 1 year
- Chronic atrial fibrillation
- Indication for long term anticoagulation therapy before the index procedure
- Mechanical valve implantation previously or at the index procedure
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02321137 |
| CCMO | NL55356.100.15 |