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Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy (COMPARE-LAAO)

Primary Purpose

Atrial Fibrillation, Anticoagulants and Bleeding Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)
Sponsored by
R&D Cardiologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Anticoagulation, Left atrial appendage occlusion, Left atrial appendage, Occluder, Stroke

Eligibility Criteria

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

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

Sites / Locations

  • Medical Center Leeuwarden
  • Radboud UMC
  • Maastricht UMC
  • St Antonius HospitalRecruiting
  • Amphia Hospital
  • OLVG
  • Amsterdam UMC
  • Medical Spectrum Twente
  • Isala Clinics
  • Haga Hospital
  • Leiden UMC
  • Erasmus MC
  • UMC Groningen
  • UMC UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm - Left atrial appendage occlusion (with Watchman FLX or Amplatzer Amulet device)

Control arm - no or usual care

Arm Description

Patients randomized to the intervention arm will receive left atrial appendage occlusion. In order to prevent device-related thrombus, they will use dual antiplatelet therapy (acetylsalicylzuur + clopidogrel) for three months and single antiplatelet therapy (acetylsalicylzuur) until at least 12 months after the procedure.

The patients in the control arm will stay on optimal treatment as decided by the referring physician (antiplatelet therapy or nothing).

Outcomes

Primary Outcome Measures

Time to first occurrence of ischemic or hemorrhagic or undetermined stroke.
Time to first occurrence of the composite of stroke (ischemic or hemorrhagic or undetermined), TIA and systemic embolism.
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

Secondary Outcome Measures

The composite event rate of stroke (ischemic or hemorrhagic), TIA, systemic embolism and cardiovascular death.
Ischemic stroke event rate
Disabling stroke event rate
Hemorrhagic stroke event rate
TIA event rate
Systemic embolism (SE) event rate
Mortality (cardiovascular) event rate
Mortality (all-cause) event rate
Major bleeding event rate (according to BARC criteria)
Minor bleeding event rate
Number of patients with successful device deployment
Adverse events rate
Device related thrombus event rate
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)
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.
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
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.
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.
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.

Full Information

First Posted
November 25, 2020
Last Updated
December 19, 2022
Sponsor
R&D Cardiologie
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04676880
Brief Title
Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy
Acronym
COMPARE-LAAO
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
R&D Cardiologie
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 in women, anticoagulation should be considered (class IIA, loe-B). When the CHA2DS2-VASc score is 2 or greater in men (3 or greater in women) anticoagulation is recommended in all with a Class I, loe-A, preferably with a NOAC (class I, loe-A). Platelet inhibitor monotherapy is prohibited with a Class III, loe-A. Patients that have or develop a long-term contra-indication for oral anticoagulation have no class I guideline accepted alternative. Instead it is recommended to modify conditions or interrupt anticoagulants (Class IIB, loe-B). Resumption of oral anticoagulants should be guided by a multidisciplinary team that weighs the risks and benefits of such a course of action (class IIA, loe-C). In patients after an intracranial haemorrhage (ICH), it is recommended to initiate or resume anticoagulation after 2-4 weeks (class IIA, loeC) choosing an agent with low intracranial bleeding risk. There is insufficient data to support the choice of anticoagulant and no evidence at all for avoiding stroke prevention altogether, which has led to wide variations in restarting oral anticoagulation often after several months of abstinence. Over 60% does not even resume therapy after anticoagulation-associated ICH. As the LAA is the dominant source for cardioembolic stroke, mechanical percutaneous endocardial occlusion procedures have been developed. The WATCHMAN and AMULET (both FDA- and CE approval) are the most used but others are emerging. Basically, a cardiac catheterization is performed from the Femoral Vein, passing a 14F catheter through the Inferior Caval Vein and the interatrial septum to the left atrium. The delivery system is then positioned in the LAA ostium, and the device is deployed blocking the entrance and eliminating the LAA from the circulation. The implant procedure is usually guided by trans-esophageal echo imaging to assess device size and determine optimal position before it can be released. Adequate closure is achieved in 99% of patients nowadays, with a low and manageable procedural risk of 2.5%. To avoid device-related thrombus during reendothelialization patients are treated with dual antithrombotic agents, aspirin and clopidogrel in the first 3 months, which is narrowed down to aspirin until 1 year after which time it may be discontinued. The 5-year follow up of PROTECT-AF and PREVAIL showed that LAAO was non-inferior to vitamin K antagonist (VKA) for the primary endpoint of stroke/ TIA/systemic embolism/death (HR 0.82, p-value 0.3), while VKA-patients had significantly more major bleeding events after the implant (HR 0.48, p=0.0003). WATCHMAN LAAO is CE and FDA approved and worldwide almost 100.000 WATCHMAN implantations have now been performed. Currently no RCT outcome data are available comparing WATCHMAN LAAO to any type of NOAC. For AMULET and other LAAO devices there are no published RCT compared to either VKA or NOAC. The EWOLUTION all-comers registry data in over 1000 AF pts (73% unable to use (N)OAC, CHA2DS2-VASc 4.7) WATCHMAN LAAO showed stroke and bleeding rates 80% and 46% lower than expected compared to historical data. In 2 similar AMPLATZER-AMULET LAAO registries of >1000 AF patients, stroke and bleeding rates were 50-60% lower. Both in the 2020 ESC and the 2019 AHA/ACC guidelines, LAAO has received a Class IIb, loe-B recommendation for stroke prevention in patients with AF that have non-reversible contra-indications for long-term anticoagulation. The COMPARE-LAAO trial studies the effectiveness and safety of LAAO as an alternative means for stroke prevention, to establish whether outcomes in The Netherlands are comparable to literature. In the setting of a randomized controlled trial, LAA will be compared to usual care of anti-platelet therapy or nothing based on individual physician's assessment. Cost-effectiveness will be studied by comparing the additional cost of the procedure to cost of usual care, and the differences in cost between both arms for complications due to stroke and other embolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Anticoagulants and Bleeding Disorders
Keywords
Atrial fibrillation, Anticoagulation, Left atrial appendage occlusion, Left atrial appendage, Occluder, Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This trial is set-up as an open-label, national multicentre, superiority randomized controlled trial where patients will be randomized in a 2:1 fashion to the device arm or the usual care arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
609 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm - Left atrial appendage occlusion (with Watchman FLX or Amplatzer Amulet device)
Arm Type
Experimental
Arm Description
Patients randomized to the intervention arm will receive left atrial appendage occlusion. In order to prevent device-related thrombus, they will use dual antiplatelet therapy (acetylsalicylzuur + clopidogrel) for three months and single antiplatelet therapy (acetylsalicylzuur) until at least 12 months after the procedure.
Arm Title
Control arm - no or usual care
Arm Type
No Intervention
Arm Description
The patients in the control arm will stay on optimal treatment as decided by the referring physician (antiplatelet therapy or nothing).
Intervention Type
Device
Intervention Name(s)
Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)
Other Intervention Name(s)
Watchman FLX device, Amplatzer Amulet device
Intervention Description
Currently, there are two devices available on the Dutch market, Watchman and Amulet. After randomization to the intervention arm, additional randomization for type of device will follow. If the amount of procedures is too small to implant two devices, the centre will implant a device of choice.
Primary Outcome Measure Information:
Title
Time to first occurrence of ischemic or hemorrhagic or undetermined stroke.
Time Frame
Minimal follow up is 1 year, maximum follow up +/- 5 years
Title
Time to first occurrence of the composite of stroke (ischemic or hemorrhagic or undetermined), TIA and systemic embolism.
Time Frame
Minimal follow up is 1 year, maximum follow up +/- 5 years
Title
Incidence of procedural complications
Description
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
Time Frame
Procedure up to 30 days
Secondary Outcome Measure Information:
Title
The composite event rate of stroke (ischemic or hemorrhagic), TIA, systemic embolism and cardiovascular death.
Time Frame
Through study completion, an average of 3 years
Title
Ischemic stroke event rate
Time Frame
Through study completion, an average of 3 years
Title
Disabling stroke event rate
Time Frame
Through study completion, an average of 3 years
Title
Hemorrhagic stroke event rate
Time Frame
Through study completion, an average of 3 years
Title
TIA event rate
Time Frame
Through study completion, an average of 3 years
Title
Systemic embolism (SE) event rate
Time Frame
Through study completion, an average of 3 years
Title
Mortality (cardiovascular) event rate
Time Frame
Through study completion, an average of 3 years
Title
Mortality (all-cause) event rate
Time Frame
Through study completion, an average of 3 years
Title
Major bleeding event rate (according to BARC criteria)
Time Frame
both procedural up to 7 days, as well as total (through study completion, an average of 3 years)
Title
Minor bleeding event rate
Time Frame
both procedural up to 7 days, as well as total (through study completion, an average of 3 years)
Title
Number of patients with successful device deployment
Time Frame
procedural up to 7 days
Title
Adverse events rate
Time Frame
at 30 days, and from 30 days until end of follow up (max. 5 years, avarage of 3 years)
Title
Device related thrombus event rate
Time Frame
Through study completion, an average of 3 years
Title
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)
Time Frame
Through study completion, an average of 3 years
Title
Patient-reported health quality assessed by the SF12 questionnaire
Description
SF-12 stands for 12-Item Short Form Health Survey. Every question is scored from 1 to 5 points. Higher scores indicate better outcomes.
Time Frame
baseline, 3, 6, 12 months, after that on a yearly base (until the end of the study, max follow up +/- 5 years)
Title
Anxiety and depression assessed by the HADS questionnaire
Description
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
Time Frame
baseline, 3, 6, 12 months, after that on a yearly base (until the end of the study, max follow up +/- 5 years)
Title
Generic health status assessed by the EQ5D5L questionnaire (in order to perform a cost-effectiveness analysis)
Description
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.
Time Frame
Through study completion, an average of 3 years. Questionnaires will be send on a half yearly basis.
Title
Medical consumption (in order to perform a cost-effectiveness analysis)
Description
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.
Time Frame
Through study completion, an average of 3 years. Questionnaires will be send on a half yearly basis.
Title
Productivity losses (in order to perform a cost-effectiveness analysis)
Description
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.
Time Frame
Through study completion, an average of 3 years. Questionnaires will be send on a half yearly basis.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas VA Boersma, Prof. Dr.
Phone
+31 (0)88 320 0900
Email
l.boersma@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Bosschaert, Drs.
Phone
+31 (0)88 320 0900
Email
m.bosschaert@antoniusziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas VA Boersma, Prof. Dr.
Organizational Affiliation
St Antonius Ziekenhuis Nieuwegein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Leeuwarden
City
Leeuwarden
State/Province
Friesland
ZIP/Postal Code
8934 AD
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Radboud UMC
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sjoerd Westra, MD
Facility Name
Maastricht UMC
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisevi Chaldoupi, MD, PhD
Facility Name
St Antonius Hospital
City
Nieuwegein
State/Province
Noord Holland
ZIP/Postal Code
3435 CM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Boersma, prof. dr.
First Name & Middle Initial & Last Name & Degree
Marina Huijboom
Phone
+31 88 320 0900
Email
m.huijboom@antoniusziekenhuis.nl
Facility Name
Amphia Hospital
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander IJsselmuiden, MD, PhD
Facility Name
OLVG
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1091 AC
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muchtiar Khan, MD
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joris de Groot, MD, PhD
Facility Name
Medical Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7512 KZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Stevenhagen, MD, PhD
Facility Name
Isala Clinics
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 BT
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arif Elvan, MD, PhD
Facility Name
Haga Hospital
City
Den Haag
State/Province
Zuid Holland
ZIP/Postal Code
2545 AA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen van der Heijden, MD, PhD
Facility Name
Leiden UMC
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank van der Kley, MD
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
UMC Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Vlachojannis, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
During/at the end of the study, the database will be transfered to the 'Dutch Heart Registry' (https://nederlandsehartregistratie.nl/). This registry keeps track of all implantable devices that are within the national health insurance package. In this way, data can be obtained by other researchers (fair data principle).
IPD Sharing Time Frame
After publishing the main study articles, all data will be available.
IPD Sharing Access Criteria
Specific degrees in the field of research have to be demonstrated, as well as links with hospitals or research institutes (e.g. an employee contract) of the researcher/physician.
Citations:
PubMed Identifier
35537503
Citation
Huijboom M, Maarse M, Aarnink E, van Dijk V, Swaans M, van der Heijden J, IJsselmuiden S, Folkeringa R, Blaauw Y, Elvan A, Stevenhagen J, Vlachojannis G, van der Voort P, Westra S, Chaldoupi M, Khan M, de Groot J, van der Kley F, van Mieghem N, van Dijk E, Dijkgraaf M, Tijssen J, Boersma L. COMPARE LAAO: Rationale and design of the randomized controlled trial "COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy". Am Heart J. 2022 Aug;250:45-56. doi: 10.1016/j.ahj.2022.05.001. Epub 2022 May 7.
Results Reference
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Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy

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