Completed Clinical Trials

Completed Clinical Trials

Heart Valve Studies:

Partner 3

Mitral EFS CardiAQ Study

  • Sponsor: Edwards Lifesciences
  • Sponsor Link: https://clinicaltrials.gov/ct2/show/NCT02718001
  • Study Overview: Early feasibility study to evaluate the safety and function of the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve
  • Target Population: Patients with moderate to severe mitral regurgitation
  • Study Status: Actively recruiting patients
  • Study Website Link: https://clinicaltrials.gov/ct2/show/NCT02718001
  • Principal Investigator: Dr. Pranav Loyalka, Dr. Richard W. Smalling, Dr. Igor Gregoric, Dr. Tom Nguyen, Dr. Biswajit Kar
  • To obtain more information, please contact the research staff at: 713-500-8828

Portico

  • Sponsor: St. Jude Medical
  • Sponsor Link: https://professional-intl.sjm.com/therapies/portico-transcatheter-aortic-valve/home
  • Study Overview:  A prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.
  • Target Population: Patient with Severe, symptomatic aortic stenosis at high operative risk
  • Study Status: Actively recruiting
  • Study Website Link: https://clinicaltrials.gov/ct2/show/NCT02000115?term=portico&rank=1
  • Principal Investigator: Dr. Pranav Loyalka
  • To obtain more information, please contact the research staff at: 713-500-8828

COAPT TRIAL

  • Sponsor: Abbott Vascular/Evalve Inc
  • 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 Link: http://clinicaltrials.gov/ct2/show/NCT01626079
  • Principal Investigator: Dr. Richard Smalling
  • To obtain more information, please contact the research staff at: 713-500-8828

Structural Heart Studies:

Advance ASO

  • Sponsor: St. Jude Medical
  • Sponsor Link: https://clinicaltrials.gov/ct2/show/NCT02353351
  • Study Overview: A prospective, case-cohort study, to identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZERTM Septal Occluder (ASO)
  • Target Population: Adult and Pediatric patients with an atrial septal defect requiring treatment
  • Study Status: Actively Enrolling
  • Study Website: https://clinicaltrials.gov/ct2/show/NCT02353351
  • Principal Investigator: Richard W. Smalling
  • To obtain more information, please contact the research staff at: 713-500-8828

Galileo

  • Sponsor: Bayer
  • Sponsor Link: https://clinicaltrials.gov/ct2/show/NCT02556203?term=galileo+tavr&rank=1
  • Study Overview: To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE) and To assess whether a rivaroxaban-based strategy, following TAVR, compared to an antiplatelet-based strategy, is non-inferior towards primary bleeding events (PBE).
  • Target Population: Patient with Severe, symptomatic aortic stenosis at high operative risk
  • Study Status: Actively enrolling
  • Study Website link: https://clinicaltrials.gov/ct2/show/NCT02556203?term=galileo+tavr&rank=1
  • Principal Investigator: Dr. Prakash Balan
  • To obtain more information, please contact the research staff at: 713-500-8828

Coronary Artery Disease Studies:

Complete PCI

  • Sponsor: Population Health Research Institute
  • Sponsor Link: https://clinicaltrials.gov/ct2/show/NCT01740479?term=complete&rank=2
  • Study overview: To determine whether, on a background of optimal medical therapy, including ticagrelor, opening of all suitable narrowings or blockages found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.
  • Target Population: Patients who have had an acute myocardial infarction
  • Study Status: Actively enrolling
  • Study Website Link: https://clinicaltrials.gov/ct2/show/NCT01740479?term=complete&rank=2
  • Principal Investigator: Dr. Salman Arain
  • To obtain more information, please contact the research staff at: 713-500-8828
  • CURRENT CLINICAL TRIALS THAT ARE CLOSED FOR PATIENT ENROLLMENT

Heart Valve Studies:

PARTNER II Trial

  • Sponsor: Edwards Lifesciences
  • 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: Closed for new enrollment
  • Study Website Link: http://clinicaltrials.gov/ct2/show/NCT01314313
  • Principal Investigator: Dr. Richard Smalling

EVEREST II – REALISM

  • Sponsor: Abbott Vascular/Evalve Inc
  • 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 Link: http://clinicaltrials.gov/ct2/show/NCT01495364
  • Principal Investigator: Dr. Richard Smalling
  • To obtain more information, please contact the research staff at: 713-500-8828

SENTINEL Study

  • Sponsor: Claret Medical
  • Sponsor Link: http://www.claretmedical.com/clinical-evidence/randomized-trials/#tab-id-3
  • Study Overview: The purpose of this research study is to study the safety and effectiveness of the Sentinel System for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.
  • Target Population: Patients with severe aortic stenosis
  • Study Status: Closed for new enrollment
  • Study Website Link: https://clinicaltrials.gov/ct2/show/NCT02214277
  • Principal Investigator: Dr. Richard Smalling

Acute Myocardial Infarction Studies:

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: Closed for new enrollment
  • Study Website Link: http://clinicaltrials.gov/ct2/show/NCT01458405?term=allstar+capricor&rank=1
  • Principal Investigator: Dr. H.V. Anderson
  • To obtain more information, please contact the research staff at: 713-500-8828

PRESERVE AMI TRIAL

  • Sponsor: Amorcyte, Inc./Neostem
  • Sponsor Link: http://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: Closed for new enrollment
  • Study Website Links: http://www.neostem.com/assets/PreSERVE-AMI-Trial-Overview.pdf
    http://clinicaltrials.gov/ct2/show/NCT01495364
  • Principal Investigator: Dr. Hildreth Vernon Anderson

Structural Heart Studies:

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: Closed for new enrollment
  • Study Website Link: http://clinicaltrials.gov/ct2/show/NCT00465270
  • Principal Investigator: Dr. Richard Smalling
  • To obtain more information, please contact the research staff at: 713-500-8828

Heart Failure Studies:

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: Closed for new enrollment
  • Study Website Link: http://clinicaltrials.gov/ct2/show/NCT01584557?term=tolvaptan&rank=12
  • Principal Investigator: Dr. Prakash Balan
  • To obtain more information, please contact the research staff at: 713-500-8828

Preventative Cardiology/General Cardiology Studies:

Spire 1 Study

  • Sponsor: Pfizer
  • Sponsor Link: http://spirestudies.com/
  • Study Overview: This study is investigating a study drug in people who have high cholesterol. This study drug is being evaluated to understand its effects on bad cholesterol (LDL-C) and cardiovascular events such as heart attack or stroke.
  • Target Population: Patients with high cholesterol
  • Study Status: Closed for new enrollment
  • Study Website Link: https://clinicaltrials.gov/ct2/show/NCT01975376
  • Principal Investigator: Dr. Salman Arain
  • To obtain more information, please contact the research staff at: 713-500-8828 or 713-500-5683

Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS)

  • Sponsor: Duke Clinical Research Institute
  • Sponsor Link: https://clinicaltrials.gov/ct2/show/NCT02406677?term=artemis&rank=7
  • Study Overview: The ARTEMIS trial is a practical multicenter, cluster- randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year. We hypothesize that reducing out–of–pocket cost for P2Y12 receptor inhibitor will lead to improved adherence.
  • Target Population: Patients who have had a myocardial infarction
  • Study Status: Closed for new enrollment
  • Study Website: https://clinicaltrials.gov/ct2/show/NCT02406677?term=artemis&rank=7
  • Principal Investigator: Dr. H.V. Anderson

DECLARE-TIMI 58

  • Sponsor: Astrazeneca
  • Sponsor Link: http://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: Closed for new enrollment
  • Study Website Link: http://clinicaltrials.gov/show/NCT01730534
  • Principal Investigator: Dr. Francisco Fuentes

Intrepid Trial

Sponsor: The Cleveland Clinic

Sponsor Link: https://clinicaltrials.gov/ct2/show/NCT02291419

Study Overview: An Open label, randomized study to determine the rate of cardiovascular events at 1 year for patients with elevated troponins post major non-cardiac surgery and the impact of ticagrelor versus aspirin on the occurrence of cardiovascular events.

Target Population: Patients with severe aortic stenosis

Study Status: Actively recruiting patients

Study Website Link: https://clinicaltrials.gov/ct2/show/NCT02291419

Principal Investigator: Dr. Francisco Fuentes

To obtain more information, please contact the research staff at: 713-500-8828

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 Link: http://clinicaltrials.gov/ct2/show/NCT00403078

Principal Investigator: Dr. Richard Smalling

To obtain more information, please contact the research staff at: 713-500-8828

REGULATE-PCI

Sponsor: Regado Biosciences, Inc

Sponsor Link: http://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 urgent 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

To obtain more information, please contact the research staff at: 713-500-8828