National Leaders in Cardiac Research
Our nationally recognized cardiovascular research program is designed to provide state of the art, inventive approaches to clinical trial management. At Houston Heart, our team pioneers clinical trials to constantly innovate solutions and improve patient outcomes. Our physicians actively manage multiple studies with HCA Research Institute.
Condition: Tricuspid Regurgitation
Trial: Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve repair System Pivotal (TRILUMINATE)
Intervention: The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic Patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
Sponsor: Abbott
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Status: ACTIVE; enrolling
Condition: mitral Valve Regurgitation
Trial: Percutaneous MitraClip Device or Surgical mitral Valve repair in Patients With primary mitral Regurgitation Who Are Candidates for Surgery (repair MR)
Intervention: The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in Patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Sponsor: Abbott
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Status ACTIVE; enrolling
Condition: mitral Valve Regurgitation
Trial: Edwards PASCAL Transcatheter Valve repair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter mitral valve repair With the Edwards PASCAL Transcatheter Valve repair System Compared to Abbott MitraClip in Patients With mitral Regurgitation (CLASP IID + IIF)
Intervention: To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve repair System in Patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in Patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT).
Sponsor: Edwards Lifesciences
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Status ACTIVE; enrolling
Condition: Atrial Septal Defect, Congenital Heart Disease, Patent Foramen Ovale
Trial: OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS (AMPLATZER PFO)
Intervention: The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting for those subjects with a PFO who have had an ischemic stroke within the last 547 days.
Sponsor: Abbott
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Status: ACTIVE; enrolling
Condition: Cardiomyopathy, Congenital Heart Disease, Dilated Cardiomyopathy, Heart Failure
Trial: Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Intervention: Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in Patients with heart failure and reduced ejection fraction (HFrEF).
Sponsor: Ancora Heart
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Status: ACTIVE; enrolling
Condition: Tricuspid Regurgitation
Trial: A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve repair With the Edwards PASCAL Transcatheter Valve repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation (CLASP II TR)
Intervention: To establish the safety and effectiveness of the Edwards PASCAL Transcatheter repair System in Patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team.
Sponsor: Edwards Lifescience
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Specialty: Interventional Cardiology
Status: ACTIVE; enrolling
Condition: mitral Valve Regurgitation
Trial: The ENCIRCLE Trial
Intervention: SAPIEN M3 system is a completely percutaneous Transcatheter mitral valve replacement via transseptal access.
Sponsor: Edwards Lifesciences
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Clinical Trial
Status: ACTIVE; enrolling
Condition: Atrial Fibrillation
Trial: CATALYST Trial
Intervention: Clinical trial of atrial fibrillation Patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants.
Sponsor: Abbott
Principal Investigator: Pranav Loyalka, MD
Research Coordinator: Joan Morrison, CRC - (832) 633-5463
Research Manager: Fazal Hussain, MD - (713) 447-6205
Status: ACTIVE; enrolling