Status:
ACTIVE_NOT_RECRUITING
Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy
Lead Sponsor:
R&D Cardiologie
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Atrial Fibrillation
Anticoagulants and Bleeding Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Up to 5% of Atrial Fibrillation (AF) patients may have or develop contraindications to use oral anticoagulation (OAC). Randomized controlled trial (RCT) data suggest that Left Atrial Appendage Occlusi...
Detailed Description
Stroke risk for non-valvular AF is estimated with the CHA2DS2-VASc score. When patients have no risk factors, no anticoagulation is recommended with a Class III, loe B. With 1 risk factor in men and 2...
Eligibility Criteria
Inclusion
- Documented non-valvular AF (paroxysmal or non-paroxysmal) and
- CHA2DS2-VASc score of 2 or more and
- Unsuitable for long-term use of oral anticoagulation as determined by the referring physician team as well as the multidisciplinary team in the study hospital and
- Suitable for dual APT for at least 3 months and single APT from 3 until at most 12 months and
- At least 18 years of age, and willing and able to provide informed consent and adhere to study rules and regulations and follow-up
- The decision of suitability for LAAO should be made by a multidisciplinary team consisting of at least an echocardiographist, an implanting cardiologist, and a cardiac surgeon. The decision of unsuitability for oral anticoagulation by the referring and implanting centers will be clearly and extensively documented in the study charts. This should include the support of physicians other than the referring and implanting cardiologist. These physicians should be specialists in the field where the contra-indication arises such as neurology, gastro-enterology, internal medicine, urology, or other specialties. In many cases the contra-indication may be due to (repeated) major bleeding.Bleeding will be classified according to the BARC criteria as major with a score of 3 or more. The risk of recurrent bleeding should be established by a multidisciplinary team, as well as the decision that the risk of bleeding recurrence outweighs the benefit of restarting oral anticoagulation, which will be documented in the charts. Alternative reasons not to use anticoagulation should be major and irreversible. These may be highly variable and may include but are not limited to occupational or life-style hazards, drug side-effects, ineffectiveness, intolerance, renal or liver failure, falling hazards, vascular problems, cerebral amyloid deposition, and coagulation disorders.
Exclusion
- Any invasive cardiac procedure within 30 days prior to randomization and 90 days after LAAO that would interfere with the study follow-up and medication
- Unsuitable LAA anatomy for closure or thrombus in the LAA at the time of procedure
- Contraindications or unfavourable conditions to perform cardiac catheterization or TEE
- Atrial septal malformations, atrial septal defect or a high-risk patient foramen ovale that may cause thrombo-embolic events
- Atrial septal defect repair or closure device or a patent foramen ovale repair or any other anatomical condition as this may preclude an LAAO procedure
- LVEF\<31% and/or heart failure NYHA 3-4
- Mitral valve regurgitation grade 3 or more
- Mitral stenosis as this makes AF by definition valvular in nature
- Aortic valve stenosis (AVA\<1.0 cm2 or Pmax\>50 mmHg) or regurgitation grade 3 or more
- Planned cardiac surgery for any reason within 3 months
- Stroke within the 3 months prior to inclusion, if not yet clinically stable, and/or without adequate diagnostic or prognostic evaluation, and/or in need of other interventions NL75209.100.20 COMPARE-LAAO Study protocol version 1.4 September 2020
- Planned CEA for significant carotid artery disease
- Major bleeding (BARC criteria\>type 2) within 1 month prior to inclusion or longer if it has not been resolved yet
- Compelling medical reason to use VKA or NOAC (e.g. mechanical heart valve, pulmonary embolism, ventricular aneurysm)
- Major contraindications for using aspirin or clopidogrel
- (planned) pregnancy
- Participation in any other clinical trial that interferes with the current study
- Life expectancy of less than 1 year
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
609 Patients enrolled
Trial Details
Trial ID
NCT04676880
Start Date
January 1 2021
End Date
November 1 2026
Last Update
June 21 2024
Active Locations (14)
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1
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6525 GA
2
Maastricht UMC
Maastricht, Limburg, Netherlands, 6229 HX
3
Amphia Hospital
Breda, North Brabant, Netherlands, 4818 CK
4
OLVG
Amsterdam, North Holland, Netherlands, 1091 AC