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Selection of current studies

  • 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 

  • 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

  • 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

  • MASTER DAPT (NCT03023020)

4,300 patients, Global
Services: CEC adjudication, DSMB, Safety Reporting and Site Management BENELUX

  • Drug Eluting Stent 

1,400 patients, Europe
Services: Full study including OCT sub-study

  • Transcatheter aortic valve implantation 

2,500 patients, global
Services: protocol, CEC adjudication and DSMB

  •  CEASE AF (NCT02695277)

Hybrid surgical ablation
210 patients, Europe
Services: monitoring, regulatory submission, safety reporting, CEC adjudication and data management

  • Bioresorbable scaffold

501 patients, global
Services: core lab (OCT, IVUS, MSCT and QCA) and CEC adjudication

16,000 patients, global
Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab

  •  Safety & efficacy dose finding trial NOAC 

105 patients, Europe
Services: Monitoring, data management, CRF, CEC adjudication and DSMB

  • Heart failure: CRT-D

3,796 patients, Global
Services: Core Lab (ECHO, Angio & ECG)

  •  Transcatheter aortic valve implantation 

1,000 patients, global
Services: Core Lab (ECHO)

190 patients, Europe
Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab

450 patients, Europe
Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab

Structural Heart Core Lab

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The Cardialysis Structural Heart Core Lab provides the perfect partner in conducting transcatheter therapies clinical trials (e.g. TAVR, TMTT). Over the past few years thousands of imaging data from patients enrolled in several registries and clinical trials have been successfully analyzed and adjudicated by the Cardialysis Core Lab. These data are used for CE mark and FDA submissions. 

 

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Investigator Initiated Studies

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The European Cardiovascular Research Institute (ECRI) offers a platform for the design and conduct of international investigator-initiated clinical trials. ECRI acts as Sponsor ensuring compliance with ICH GCP guidelines and regulatory standards. Trial activities are executed by Cardialysis alone or in collaboration with renowned research organizations world-wide. 

 

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Monitoring Services

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Cardialysis offers a consolidated monitoring network across Europe. Our clinical research associates with >5 years of experience, ensure timely activation of investigational sites, high-quality data review and effective interaction with sites. With >1400 sites monitored and >150,000 patients included, Cardialysis has established a significant track record in site management.

 

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