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Selection of current studies

  • Evaluation of TAVR & Optimal Heart Failure Therapy (OHFT) versus OHFT in HF patients

600 patients, USA, Europe & Canada
Services: protocol, statistics, monitoring EU, CEC adjudication, DSMB, safety reporting EU and ECG Core Lab 

  • First in Man: Biodegradable polymer Sirolimus‐eluting stent (Chinese)

132 patients, Europe
Full-service including Core Lab

  • Post-marketing VT ablation study

382 patients, Europe and US
Regulatory Submission, Site Monitoring & Management and Safety reporting Europe

  • Evaluation of NOAC in Patients after Successful Transcatheter Aortic Valve Implantation (TAVI)

1,500 patients, Europe & US
Full-service 

  • Bioresorbable scaffold

2,690 patients, Europe
Services: CEC adjudication and SYNTAX Score analysis

  • High Bleeding Risk patients

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

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

  •  Hybride 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

  •  Coronary Artery Disease - Cardiotonic Agent

3,000 patients, Global
Services: CEC adjudication

  • Heart failure: CRT-D

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

  •  Left Atrial Appendage Occlusion 

700 patients, Europe
Services: CEC adjudication

  •  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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