Therapeutic Expertise
Cardiology - Heart Valves
Cardiovascular Experience
D-TARGET has a long tradition in cardiovascular research for medical devices. We have supported the approval of many new devices as well as post marketing studies on the following devices:
• Stents (Bare Metal and Drug Eluting)
• EP - Ablation Systems
• Valve Replacement
• CRT Devices
• Baroreflex Stimulator
• Cardiac Assist Devices
• Cardiac Bioprosthesis
• Cardiac Pressure Monitoring Devices
• Catheter (Laser and Drug Eluting)
• Drug Eluting Balloon
• Mechanical Reperfusion Device
• PFO Closure Devices
• Thoracic Endoprosthesis and Stent Grafts
D-TARGET has managed 56 cardiology medical device studies treating approximately 22,000 patients within the past 9 years. We have also provided consulting services for an additional 20 cardiology projects and are currently supporting trials in the US and throughout Central and Eastern Europe, Scandinavia and Israel.
Heart Valve Experience
D-TARGET is highly experienced in supporting studies involving heart valves, especially in percutaneus approach. We supported over the last years 13 trials with roughly 1850 patients involved throughout Europe and Israel.
As an example D-TARGET is currently supporting the clinical trial activities of a post CE Mark study for a leading percutaneus Heart Valve manufacturer. The study data, involving 1000 patients in 70 centers in 10 countries throughout Europe and Israel, will be used to support FDA regulatory approval.
KOL Network
D-TARGET is currently working with notable sites and key opinion leaders in Europe and the US.
Europe:
Leiden, Zwolle, Rotterdam, Leuven, Brussels, Geneva, Bern, Basel, Thun, Fribourg, Leipzig, Bad Nauheim, Dresden, Berlin, Munich, Bad Segeberg, Hamburg, Bad Krozingen, Munich, Bad Oyenhausen, Coburg, Vienna, Graz, Prague, Warsaw, Monaco, London, Leicester, Manchester, Milano,Lugano, Rome, Madrid, Barcelona, Stockholm, Malmö, Kopenhagen, Oslo, Rennes, Paris, Nantes, Toulouse and Bordeaux to just name a few.
US:
Boston, Philadelphia, New York, Austin, Columbus, Chicago, Oklahoma City, Cleveland, Birmingham, Charleston, Rochester, Ann Arbor, Charlottesville, San Francisco, Fresno, San Diego, Cincinnati, Denver, Los Angeles, Plano, New Haven
Start up
The D-Target start up team was involved in the activities planning from the first days of the company involvement in a 70 center aortic valve trial. This allowed timely planning all the submissions in 10 European countries in advance. D-Target provided its experience and expertise in the EC and CA submissions. Very good knowledge of the local requirements is a great advantage of the D-Target start up team. Thanks to this experience D-Target was able to complete the submission process in very effective way.
CEC Support
D-TARGET understands the critical importance of CEC support during medical device cardiology studies. For this reason, we appoint a dedicated CEC coordinator that continuously monitors patient’s safety data and ensures CEC events are entered into the CRF in cooperation with the CRAs and sites. Our CEC coordinator will also prepare and reviews CEC packages before providing the full package to the clinical events committee for their review.
Cardiology (Heart Valves) Study & Consulting Experience details
Cardiovascular |
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Indication | Device Type | Study Type | Sites | Patients | Services | Region |
Aortic Valve Replacement | Aortic Bioprosthesis | Pilot | 8 | 200 | CM, PM, RA | WE |
Aortic Valve Replacement | Aortic Valve | Pilot | 1 | 50 | Full Service | WE |
Aortic Valve Replacement (Percutaneous) | Aortic Valve | PMS | 70 | 1,000 | CM, PM | WE, NO, ME |
Mitral Valve Regurgitation | Mitral Valve Repair | Pilot | 3 | 20 | CM, MM, MW PM, RA | WE |
Mitral Valve Regurgitation | Mitral Valve Repair | Pivotal | 20 | 90 | CM, MM, MW PM, RA | WE, NO |
Mitral Valve Regurgitation | Mitral Valve Repair | Pilot | 6 | 40 | CM, MM, PM, QA, RA | WE |
Mitral Valve Regurgitation | Mitral Valve Repair | Pilot | 3 | 30 | CM, MM, PM, QA, RA | WE |
Severe Aortic Valve Disease | Transcatheter Heart Valve | Pilot | 3 | 30 | CM, PM | WE |
Severe Aortic Valve Disease | Transcatheter Heart Valve | Pivotal | 8 | 150 | DM | WE |
Aortic Valve Replacement ( percutaneous ) | Aortic Bioprosthesis | PMS | 12 | 200 | CM, SUM, PM | WE |
Aortic Valve Replacement ( percutaneous ) | Aortic Bioprosthesis | Pilot | 1 | 20 | CM | CE |
Aortic Valve Replacement ( percutaneous ) | Aortic Bioprosthesis | Pilot | 1 | 20 | CM | CE |
Valve Replacement | Aortic Valve | Consulting |
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Valve Replacement | Aortic Valve | Consulting |
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Services |
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BS CM DB DM FS IT MM MW PM QA RC RA SS Full Service | Biostatistics Clinical Monitoring & Management Data Safety Monitoring Board Data Management Functional Sourcing IVRS/ IWRS Medical Management Medical Writing Project Management Quality Assurance Research Centers Regulatory Affairs Study Start-Up 4 or more services including BS, CM, DM & PM | NA WE CE EE AF AP AU CA ME NO SA
| North America Western Europe Central Europe Eastern Europe Africa Asia/Pacific Australasia Central America Middle East Nordics South America
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