Division of Cardiovascular Diseases
School of Medicine > Cardiovascular > Clinical Trials
School of Medicine > Cardiovascular > Clinical Trials
| Study Name | PI | Sponsor | Major Comparison | Begun | Status |
|---|---|---|---|---|---|
| Amplatzer Cardiac Plug | Peter Tadros, MD | SJM/AGA | Study of device for left atrial appendage occlusion | Pending | Start-up |
| Cardiac Lead Assessment Study | Dhanunjaya Lakkireddy, MD | St.Jude Medical | Imaging study to identify erosions in SJM leads | Pending | Start-up |
| PLACE III | Dhanunjaya Lakkireddy, MD | SentreHeart | Lariat procedure in AF patients | Pending | Start-up |
| H-FIB | Dhanunjaya Lakkireddy, MD | Mt.Sinai SOM | Study of renal denervaton in conjuction with RFA for prevention of AF recurrence in patients with AF & HTN | Pending | Start-up |
| ATTAIN Performa | Loren Berenbom, MD | Medtronic | IDE study of the Attain performa quadripolar LV lead | Pending | Start-up |
| LifeCells CLI | Buddhadeb Dawn, MD | LifeCells LLC | Study of ASCT01 vs placebo in patients with critical limb ischemia | Pending | Start-up |
| BLOCK-CTI | Martin Emert, MD | Bos Sci | Investigational open irrigated RFA catheter for treatment of type1 atrial flutter | Pending | Start-up |
| ABSORB RCT | Mark Wiley, MD | AVD | IDE study of bio-resorbable coronary stent system vs XIENCE DES | Pending | Start-up |
| ATTAC-AF | Daon, MD | Estech | Surgical ablation for concomitant AF in surgical patients | 02/2013 | Enrolling |
| Wound Care 360 Site Seal | Martin Emert | Wound Care 360 Inc. | Study of the SiteSeal vascular closure device compared to manual compression in patients undergoing elective angiography +/- PCI | 01/2013 | Enrolling |
| SUR-TAVI | Trip Zorn, MD | Medtronic | TAVI in intermediate surgical risk patients | 12/2012 | Enrolling |
| COAPT | Peter Tadros, MD | Abbott Vascular | Mitraclip vs Standard Care | 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 | 12/2012 | Enrolling |
| Thermocool CA | Dhanunjaya Lakkireddy, MD | Biosense Webster | continued access protocol for ThermoCool SmartTouch catheter | 8/2012 | Enrolling |
| 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 Use | Trip Zorn, MD | Medtronic | TAVI in high surgical risk patients | 12/2012 | Enrolling |
| 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 | 10/2012 | Enrolling |
| 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 | 11/2012 | 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 | In Follow-up |
| 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 | In Follow-up |
| 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 | In Follow-up |
| 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 | In Follow-up |
| RESCUE | IWetzel, MD | ACRIN | Comparison of SPECT vs CTA | 01/2012 | 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 | Closing |
| CoreValve US Pivotal Trial | Trip Zorn, MD | Medtronic | comparison of the endovascular aortic valve replacement vs surgical replacement | 01/2011 | In Follow-up |
| 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 |
| 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 |