Selection of current studies
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TAVR UNLOAD (NCT02661451)
Randomized, IDE trial on TAVR for moderate aortic stenosis in patient with heart failure and reduced LVEF
300 patients, USA, Europe & Canada
Services: protocol, statistics, monitoring EU, CEC adjudication, DSMB, safety reporting EU and ECG Core Lab
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DEEP PIVOTAL (NCT02393885)
Dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
220 patients, Europe and US
Regulatory Submission, Site Monitoring & Management and Safety reporting Europe
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COMPARE ABSORB (NCT02486068)
Bioresorbable Scaffold vs. Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis
1,670 patients, Europe
Services: CEC adjudication and SYNTAX Score analysis
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MASTER DAPT (NCT03023020)
4,300 patients, Global
Services: CEC adjudication, DSMB, Safety Reporting and Site Management BENELUX
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Drug Eluting Stent
1,400 patients, Europe
Services: Full study including OCT sub-study
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Transcatheter aortic valve implantation
2,500 patients, global
Services: protocol, CEC adjudication and DSMB
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CEASE AF (NCT02695277)
Hybrid surgical ablation
210 patients, Europe
Services: monitoring, regulatory submission, safety reporting, CEC adjudication and data management
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Bioresorbable scaffold
501 patients, global
Services: core lab (OCT, IVUS, MSCT and QCA) and CEC adjudication
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PCI and DAPT - click here for trial details
16,000 patients, global
Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab
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Safety & efficacy dose finding trial NOAC
105 patients, Europe
Services: Monitoring, data management, CRF, CEC adjudication and DSMB
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Heart failure: CRT-D
3,796 patients, Global
Services: Core Lab (ECHO, Angio & ECG)
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Transcatheter aortic valve implantation
1,000 patients, global
Services: Core Lab (ECHO)
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Bioresorbable scaffold - click here for trial details
190 patients, Europe
Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab
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PCI in three-vessel disease (3VD) - click here for trial details
450 patients, Europe
Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab