Division ofCardiovascular Medicine

Division of Cardiology Research Program Manager:

Elizabeth Turrentine, MPH, CCRP

E: elizabeth.p.turrentine@uth.tmc.edu

P: 713-500-5683

 

Current Clinical Trials: Open for Patient Recruitment

 

PARTNER II Trial

Sponsor: Edwards Lifesciences

Sponsor Linkhttp://www.edwards.com/products/transcathetervalve/Pages/THVcategory.aspx

Study Overview: The purpose of this research study is to study the safety and effectiveness of the Edwards SAPIEN XT™ Transcatheter Heart Valve (THV) and associated delivery systems (transfemoral, transapical and transaortic) which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Target Population: Patients with severe aortic stenosis

Study Status: Actively recruiting patients

Study Website Linkhttp://clinicaltrials.gov/ct2/show/NCT01314313

Principal Investigator: Dr. Richard Smalling

Research Coordinators:
Susan Davidson
E: susan.l.davidson@uth.tmc.edu
P: 713-500-5219

Belinda Metts

E: belinda.j.metts@uth.tmc.edu

P:713-500-5219

 

COAPT Trial

Sponsor: Abbott Vascular/Evalve Inc

Sponsor Linkhttp://www.abbottvascular.com/int/mitraclip.html

Study Overview: The purpose of the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in high surgical risk subjects

Target Population: Patients with Mitral Valve Regurgitation

Study Status: Actively recruiting patients

Study Website Linkhttp://clinicaltrials.gov/ct2/show/NCT01626079

Principal Investigator: Dr. Richard Smalling

Research Coordinator:
Rhonda Patterson
E: rhonda.s.patterson@uth.tmc.edu
P: 713-500-6550

 

THE SECRET OF CHF

Sponsor: Cardiovascular Clinical Science  Foundation

Study Overview: The SECRET of CHF Study will evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy.

Target Population: Patients admitted to the hospital with heart failure and volume overload

Study Status: Actively recruiting patients

Study Website Link: http://clinicaltrials.gov/ct2/show/NCT01584557?term=tolvaptan&rank=12

Principal Investigator: Dr. Prakash Balan

Research Coordinator:
Deborah Barr
E: deborah.d.barr@uth.tmc.edu
P: 713-500-6598

ALLSTAR

Sponsor: Capricor

Sponsor Link: http://capricor.com/clinical-trials/

Study Overview: The ALLSTAR Study will evaluate the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells (Stem Cells) in Patients With an Anterior Heart Attack and Ischemic Left Ventricular Dysfunction

Target Population: Patients with previous heart attack (within 1 month – 12 months of study treatment)

Study Status: Actively recruiting patients

Study Website Link: http://clinicaltrials.gov/ct2/show/NCT01458405?term=allstar+capricor&rank=1

Principal Investigator: Dr. H.V. Anderson

Research Coordinator:
Deborah Barr
E: deborah.d.barr@uth.tmc.edu
P: 713-500-6598

 

Current Clinical Trials: Closed for patient enrollment

SAPPHIRE

Sponsor: Cordis

Study Overview: The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. This a post-market registry study that will allow Cordis, the manufacturer of the Cordis PRECISE Nitinol Stent System and the Cordis ANGIOGUARD XP/RX Emboli Capture Guidewire (ECGW) and next generation Cordis carotid stents and EPDs devices as they become commercially available to collect information about the stent and distal protection and the patients who are treated with it. The ECGW is a tiny filter basket at the end of the Guidewire in the shape of an umbrella intended to capture debris that might be released during the procedure and help reduce the chance of stroke.

Target Population: Patients with obstructive carotid artery disease receiving a Cordis stent system

Study Status: Actively recruiting patients

Study Website Linkhttp://clinicaltrials.gov/ct2/show/NCT00403078

Principal Investigator: Dr. Richard Smalling

Research Coordinator:
Rhonda Patterson
E: rhonda.s.patterson@uth.tmc.edu
P: 713-500-6550

 

PRESERVE AMI Trial

Sponsor: Amorcyte, Inc./Neostem

Sponsor Linkhttp://www.neostem.com/research-and-development/overview/

Study Overview: This study is being done to find out if putting specialized cells collected from your bone marrow (AMR-001) can preserve heart muscle function after being injected into the coronary (heart) artery that caused your heart attack. Studies have shown that people who have had a moderate or severe heart attack like the one you had, are significantly more likely to have chronic heart problems such as heart failure, than people who have had a mild heart attack. Heart failure is a serious disease and is a leading cause of death according to the American Heart Association. Studies performed with animals and a small number of humans have demonstrated that infusion of AMR-001 may preserve the performance of the heart after a heart attack.

Target Population: Patients who have recently suffered a heart attack

Study Status: Enrollment is closed

Study Website Linkshttp://www.neostem.com/assets/PreSERVE-AMI-Trial-Overview.pdf
http://clinicaltrials.gov/ct2/show/NCT01495364

Principal Investigator: Dr. Hildreth Vernon Anderson

Research Coordinator:
Deborah Barr
E: deborah.d.barr@uth.tmc.edu
P: 713-500-6598

 

EVEREST II – REALISM

Sponsor: Abbott Vascular/Evalve Inc

Sponsor Linkhttp://www.abbottvascular.com/int/mitraclip.html

Study Overview: The purpose of the study is to continue evaluation and monitoring of the safety and effectiveness of an investigational device that repairs the mitral valve. The device is called the MitraClip® System. Evalve, Inc. of Menlo Park, CA is the company that makes this device. The device consists of a delivery catheter and an implantable Clip (called the MitraClip device). The delivery catheter guides the MitraClip device into place so that it can be attached to the leaflets of your mitral valve. Once the MitraClip device is in place on your mitral valve, the delivery catheter is removed.

Target Population: Patients with Mitral Valve Regurgitation

Study Status: Enrollment is Closed

Study Website Linkhttp://clinicaltrials.gov/ct2/show/NCT01495364

Principal Investigator: Dr. Richard Smalling

Research Coordinator:
Rhonda Patterson
E: rhonda.s.patterson@uth.tmc.edu
P: 713-500-6550

RESPECT

Sponsor: AGA Medical Corporation

Study Overview: The objective of this study is to investigate whether percutaneous PFO closure is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.

Target Population: Patients with a PFO with history of a cryptogenic stroke

Study Status: Enrollment is Closed

Study Website Link: http://clinicaltrials.gov/ct2/show/NCT00465270

Principal Investigator: Dr. Richard Smalling

Research Coordinator:
Belinda Metts
E: belinda.j.metts@uth.tmc.edu
P: 713-500-5214

 

REGULATE-PCI

Sponsor: Regado Biosciences, Inc

Sponsor Linkhttp://www.astrazeneca.com/Research

Study Overview: The REGULATE-PCI  study will evaluate the safety and efficacy of the REG1 anticoagulation system compared to bivalirudin in patients with coronary artery disease (CAD) undergoing Percutaneous Coronary Intervention (PCI) for preventing the composite of death, nonfatal infarction, nonfatal stroke and urent target lesion revascularization (TLR) through day three.

Target Population: Patients with Coronary Artery Disease (CAD) undergoing a Percutaneous Coronary Intervention (PCI)

Study Status: Enrollment is closed

Study Website Link: http://clinicaltrials.gov/show/NCT01848106

Principal Investigator: Dr. Prakash Balan

Research Coordinator:
Robert Lee
E: robert.lee@uth.tmc.edu
P: 713-500-6889

DECLARE-TIMI 58

Sponsor: Astrazeneca

Sponsor Linkhttp://www.astrazeneca.com/Research

Study Overview: The purpose of this study is to see if a new investigational drug called dapagliflozin when added to your current treatment for diabetes is effective in reducing cardiovascular events such as heart attack, stroke, and death from heart disease, when compared with placebo (inactive pill having no effect).

Target Population: Patients with type II diabetes with cardiovascular disease or cardiovascular risk factors

Study Status: Enrollment is closed

Study Website Linkhttp://clinicaltrials.gov/show/NCT01730534

Principal Investigator: Dr. Fransisco Fuentes

Research Coordinator:
Deborah Barr
E: deborah.d.barr@uth.tmc.edu
P: 713-500-6598

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