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Clinical Trials

Study NamePISponsorMajor ComparisonBegunStatus
SUR-TAVI Trip Zorn, MD Medtronic Study to evaluate the safety and efficacy of transcatheter aortic valve implantation in patients with severe, symptomatic aortic stenosis at intermediate surgical risk pending Start-up
COAPT Peter Tadros, MD Abbott Vascular Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Extreme High Surgical Risk Subjects pending Start-up
OAT Trial Dhanunjaya Lakkireddy, MD Biosense Webster safety of oral anticoagulation therapy withdrawal after PVI in pts with AF and high risk factors for embolic events pending Start-up
Thermocool CA Dhanunjaya Lakkireddy, MD Biosense Webster continued access protocol for ThermoCool SmartTouch catheter pending Start-up
REDUCE PFO Peter Tadros, MD WL Gore pfo closure using the HELEX device vs medical management in patients with recurrent cryptogenic stroke and PFO pending Start-up
CoreValve Expanded Access Trip Zorn, MD Medtronic CoreValve access for intermediate risk patients pending Start-up
ACCENT MRI Rhea Pimentel, MD St. Jude Medical IDE study of the ACCENT MRITM pacemaker and Tendril MRITM lead pending Start-up
Eisenmenger QuERI Kevin Mulhern, MD Actelion observational registry of adult congenital heart defect patients at high risk for Eisenmengers Syndrome pending Start-up
NAVISTAR Dhanunjaya Lakkireddy, MD Biosense Webster observational post-approval study  of thermocool catheter in younger and older drug refractory AF pts pending Start-up
GLORIA AF Dhanunjaya Lakkireddy, MD Boehringer Ingelheim Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients with Atrial Fibrillation (Phase II/III) pending Start-up
ACHD QuERI Kevin Mulhern, MD Actelion observational registry of adult congenital heart defect patients pending Start-up
PRESERVE AMI Buddhadeb Dawn, MD Amorcyte Study of autologous CD34+ coronary infusion in STEMI 08/2012 Enrolling
IN.PACT SFA Kamal Gupta, MD Medtronic investigational drug-eluting balloon vs standard PTA for treatment of SFA/PPA lesions 08/2012 Enrolling
CACZ885M2301 Mark Wiley, MD Novartis investigational anti-inflammatory drug vs placebo in post MI pts, drug given as quarterly subQ injections 07/2012 Enrolling
ORBIT II Ashwani Mehta, MD Cardiovascular Systems, Inc. Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360 Orbital Atherectomy System in heavily calcified denovo lesions 06/2012 Enrolling
SureScan Dhanunjaya Lakkireddy, MD Medtronic post approval study of MRI-compatible ICD system 06/2012 Enrolling
ICD-TEA Loren Berenbom, MD Medtronic study of force required to extract ICD leads 06/2012 Enrolling
Sarcoid Registry Dhanunjaya Lakkireddy, MD University of Michigan prospective cardiac sarcoidosis registry 04/2012 Enrolling
CoreValve Continued Access Trip Zorn, MD Medtronic continued access study for extreme risk patients 03/2012 Enrolling
HEARTLIGHT Dhanunjaya Lakkireddy, MD Cardiofocus IDE study of endoscopic ablation system 03/2012 Enrolling
Analyze-ST Raghuveer Dendi, MD St. Jude Medical IDE study of ICD with ST change monitoring capability 03/2012 Enrolling
VISIBILITY Iliac Kamal Gupta, MD ev3 study of the Visi-ProTM Balloon Expandable Stent System (Visi-Pro stent) in the treatment of lesions in common and/or external iliac lesions 02/2012 Enrolling
DURABILITY Iliac Kamal Gupta, MD ev3 study of the Protégé® EverFlexTM Self-Expanding Stent System and Protégé® GPSTM Self-Expanding Nitinol Stent in common and/or externa iliac lesions 02/2012 Enrolling
Thermocool Dhanunjaya Lakkireddy, MD Biosense Webster investigational ablation catheter study 09/2011 In Follow-up
CONTINUUM Kamal Gupta, MD Bard SFA stent study 05/2011 Enrolling
PRE-DETERMINE Steven Owens, MD NHLBI study to identify biological markers for SCD 03/2011 Enrolling
TRANSLATE ACS Peter Tadros, MD Eli Lilly registry of ACS pts for long term outcomes 03/2011 Enrolling
CoreValve US Pivotal Trial Trip Zorn, MD Medtronic comparison of the endovascular aortic valve replacement vs surgical replacement 01/2011 Enrolling
LAPTOP Dhanunjaya Lakkireddy, MD St. Jude Medical IDE study of catheter system to monitor left atrial pressures 10/2010 Enrolling
IRASE-AF Dhanunjaya Lakkireddy, MD St. Jude Medical study of investigational ablation catheter for treatment of AF 10/2010 In Follow-up
QuickFlex Raghuveer Dendi, MD St. Jude Medical post-approval study of the QuickFlex® model 1258T left heart pacing lead 10/2010 In Follow-up
3f Bioprosthesis Trip Zorn, MD Medtronic Post Approval Clinical Study for ATS 3f® Aortic Bioprosthesis Model 1000 06/2010 Enrolling
SJ4 Post Approval Study Loren Berenbom, MD St. Jude Medical post-approval registry of SJ4 connector 01/2010 In Follow-up
SPIRIT PRIME Mark Wiley, MD Abbott Vascular investigational DES, long length stent 01/2010 In Follow-up
DURABILITY II Peter Tadros, MD ev3 study of EverFlex Nitinol Stent system for treatment of lesions in SFA 09/2009 In Follow-up
PPP / SLS Dhanunjaya Lakkireddy, MD Medtronic long-term following of FDA-Approved MDT Cardiac Rhythm Management devices 07/2009 Enrolling
StarFix Extraction Study Loren Berenbom, MD Medtronic registry of Attain 4195 lead extractions and extraction of other MDT FDA-approved leads 07/2009 Enrolling
XIENCE V Mark Wiley, MD Abbott Vascular Registry of XIENCE Stent recipients 09/2008 In Follow-up
SCORE Loren Berenbom, MD St. Jude Medical registry study of all market-approved SJM CRM devices (PM/ICD/CRT/CRT-D/leads) 07/2008 In Follow-up
PFO ACCESS Peter Tadros, MD AGA Medical conversion of existing HDE for PFO closure device to registry 09/2007 Enrolling
TAG 05-02 Trip Zorn, MD WL Gore TAG endoprosthesis for endovascular repair of thoracic aortic aneurysm 01/2007 In Follow-up
IMPROVE IT Steven Owens, MD Schering-Plough Vytorin vs Simvastatin post-MI/ACS 05/2006 In Follow-up

     Last modified: Dec 07, 2012