Atrial Fibrillation Clinical Trial
— COMPARE-LAAOOfficial title:
Comparing Effectiveness and Safety of Left Atrial Appendage Occlusion for Non-valvular Atrial Fibrillation Patients at High Stroke Risk Unable to Use Oral Anticoagulation Therapy
Verified date | June 2024 |
Source | R&D Cardiologie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Occlusion (LAAO) may provide a non-inferior alternative for cardioembolic stroke protection in patients tolerant to OAC. However, RCT data for LAAO is lacking in patients with contra-indications to OAC using antiplatelet (APT) or no therapy as usual care. The hypothesis underlying this trial is to demonstrate that LAAO is superior to usual care for the prevention of stroke.
Status | Active, not recruiting |
Enrollment | 609 |
Est. completion date | November 1, 2026 |
Est. primary completion date | May 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Documented non-valvular AF (paroxysmal or non-paroxysmal) and 2. CHA2DS2-VASc score of 2 or more and 3. 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 4. Suitable for dual APT for at least 3 months and single APT from 3 until at most 12 months and 5. 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 Criteria: 1. 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 2. Unsuitable LAA anatomy for closure or thrombus in the LAA at the time of procedure 3. Contraindications or unfavourable conditions to perform cardiac catheterization or TEE 4. Atrial septal malformations, atrial septal defect or a high-risk patient foramen ovale that may cause thrombo-embolic events 5. 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 6. LVEF<31% and/or heart failure NYHA 3-4 7. Mitral valve regurgitation grade 3 or more 8. Mitral stenosis as this makes AF by definition valvular in nature 9. Aortic valve stenosis (AVA<1.0 cm2 or Pmax>50 mmHg) or regurgitation grade 3 or more 10. Planned cardiac surgery for any reason within 3 months 11. 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 12. Planned CEA for significant carotid artery disease 13. Major bleeding (BARC criteria>type 2) within 1 month prior to inclusion or longer if it has not been resolved yet 14. Compelling medical reason to use VKA or NOAC (e.g. mechanical heart valve, pulmonary embolism, ventricular aneurysm) 15. Major contraindications for using aspirin or clopidogrel 16. (planned) pregnancy 17. Participation in any other clinical trial that interferes with the current study 18. Life expectancy of less than 1 year |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC | Amsterdam | Noord-Holland |
Netherlands | OLVG | Amsterdam | Noord-Holland |
Netherlands | Amphia Hospital | Breda | Noord-Brabant |
Netherlands | Haga Hospital | Den Haag | Zuid Holland |
Netherlands | Medical Spectrum Twente | Enschede | Overijssel |
Netherlands | UMC Groningen | Groningen | |
Netherlands | Medical Center Leeuwarden | Leeuwarden | Friesland |
Netherlands | Leiden UMC | Leiden | Zuid-Holland |
Netherlands | Maastricht UMC | Maastricht | Limburg |
Netherlands | St Antonius Hospital | Nieuwegein | Noord Holland |
Netherlands | Radboud UMC | Nijmegen | Gelderland |
Netherlands | Erasmus MC | Rotterdam | Zuid-Holland |
Netherlands | UMC Utrecht | Utrecht | |
Netherlands | Isala Clinics | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
R&D Cardiologie | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first occurrence of ischemic or hemorrhagic or undetermined stroke. | Minimal follow up is 1 year, maximum follow up +/- 5 years | ||
Primary | Time to first occurrence of the composite of stroke (ischemic or hemorrhagic or undetermined), TIA and systemic embolism. | Minimal follow up is 1 year, maximum follow up +/- 5 years | ||
Primary | Incidence of procedural complications | Defined as major procedure-related events that require prolonged hospitalization and/or specific treatment, or that lead to permanent physical or mental disability, including but not limited to: pericardiocentesis, major access site bleeding (BARC), any other major bleeding (BARC), device dislocation from the LAA to the heart or aorta, stroke, death, or other severe complications that are considered due to the procedure | Procedure up to 30 days | |
Secondary | The composite event rate of stroke (ischemic or hemorrhagic), TIA, systemic embolism and cardiovascular death. | Through study completion, an average of 3 years | ||
Secondary | Ischemic stroke event rate | Through study completion, an average of 3 years | ||
Secondary | Disabling stroke event rate | Through study completion, an average of 3 years | ||
Secondary | Hemorrhagic stroke event rate | Through study completion, an average of 3 years | ||
Secondary | TIA event rate | Through study completion, an average of 3 years | ||
Secondary | Systemic embolism (SE) event rate | Through study completion, an average of 3 years | ||
Secondary | Mortality (cardiovascular) event rate | Through study completion, an average of 3 years | ||
Secondary | Mortality (all-cause) event rate | Through study completion, an average of 3 years | ||
Secondary | Major bleeding event rate (according to BARC criteria) | both procedural up to 7 days, as well as total (through study completion, an average of 3 years) | ||
Secondary | Minor bleeding event rate | both procedural up to 7 days, as well as total (through study completion, an average of 3 years) | ||
Secondary | Number of patients with successful device deployment | procedural up to 7 days | ||
Secondary | Adverse events rate | at 30 days, and from 30 days until end of follow up (max. 5 years, avarage of 3 years) | ||
Secondary | Device related thrombus event rate | Through study completion, an average of 3 years | ||
Secondary | Net-clinical benefit of efficacy and safety endpoint (calculated as the difference in time to first occurence of stroke, TIA and SE in both arms in comparison to the 30-day rate of procedural complications in both groups) | Through study completion, an average of 3 years | ||
Secondary | Patient-reported health quality assessed by the SF12 questionnaire | SF-12 stands for 12-Item Short Form Health Survey. Every question is scored from 1 to 5 points. Higher scores indicate better outcomes. | baseline, 3, 6, 12 months, after that on a yearly base (until the end of the study, max follow up +/- 5 years) | |
Secondary | Anxiety and depression assessed by the HADS questionnaire | HADS questionnaire stands for Hospital Anxiety and Depression Scale. The scale of the HADS-questionnaire lies between 0-21.
For both anxiety and depression, de scores indicate: 0-7 = normal 8-10 = borderline normal 11-21 = abnormal |
baseline, 3, 6, 12 months, after that on a yearly base (until the end of the study, max follow up +/- 5 years) | |
Secondary | Generic health status assessed by the EQ5D5L questionnaire (in order to perform a cost-effectiveness analysis) | EQ5D5L is a standardized instrument for measuring generic health status, widely used for (among other things) economic evaluations.
The EQ5D5L consists of 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), each with a scale/digit of 1-5 (where 1 indicates no problem and 5 indicates extreme problems). The digits for 5 dimensions can be combined in a 5-digit number describing a patients health state (this is no cardinal score). From these 5-digits numbers, a index value can be calculated. These index values will be compared between the different time frames and groups. |
Through study completion, an average of 3 years. Questionnaires will be send on a half yearly basis. | |
Secondary | Medical consumption (in order to perform a cost-effectiveness analysis) | iMCQ stands for iMTA Medical Consumption Questionnaire and is developed in order to improve standardization in measurement in health economic evaluation.
The iMCQ is a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers. |
Through study completion, an average of 3 years. Questionnaires will be send on a half yearly basis. | |
Secondary | Productivity losses (in order to perform a cost-effectiveness analysis) | iPCQ stands for iMTA Productivity Cost Questionnaire and is developed in order to improve standardization in measurement in health economic evaluation.
The iPCQ is a generic questionnaire for the measurement of productivity losses. |
Through study completion, an average of 3 years. Questionnaires will be send on a half yearly basis. |
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