Showing 1 - 7 of 7 Neal Kleiman
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

Status: Open Not Enrolling

Investigator: Neal Kleiman

Study Coordinator: Deena Victor

Phone: 713.441.4536

Brief Summary: To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. Detailed Descripti ... Read more >

CoreValve® Expanded

Status: Open Not Enrolling

Investigator: Neal Kleiman

Study Coordinator: Deena Victor

Phone: 713.441.4536

The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidi ... Read more >

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF)

Status: Enrolling

Investigator: Neal Kleiman

Study Coordinator: Deena Victor

Phone: 713.441.4536

Brief Summary: 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 surger ... Read more >

Evolut EXPAND TAVR II Pivotal Trial

Status: Enrolling

Investigator: Neal Kleiman

Study Coordinator: Deena Victor

Phone: 713.441.4536

Brief Summary: Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS. Detailed Description: Multi-center, international, prospective, randomized ... Read more >

Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function (PROTECT IV)

Status: Enrolling

Investigator: Neal Kleiman

Study Coordinator: Padmaja Naik

Phone: 713.441.7386

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart p ... Read more >

SURTAVI

Status: Open Not Enrolling

Investigator: Neal Kleiman

Study Coordinator: Tia McGaughy

Phone: 346.238.4576

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgic ... Read more >

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. (APOLLO)

Status: Enrolling

Investigator: Neal Kleiman

Study Coordinator: Tia McGaughy

Phone: 346.238.4576

Brief Summary: Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Inclusion Criteria: Moderate to severe or severe symptomatic mitral regurgitation Loca ... Read more >