Showing 1 - 10 of 15 valve disease
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

Status: 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 >

AltaValve Early Feasibility Study Protocol

Status: Open Not Enrolling

Investigator: Michael Reardon

Study Coordinator: Iris Alanis

Phone: 713.441.6548

Brief Summary: Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortalit ... Read more >

Amplatzer Amulet LAAO vs. NOAC (CATALYST)

Status: Enrolling

Investigator: Miguel Valderrabano

Study Coordinator: Aneesch Martin

Phone: 713.441.6548

Brief Summary: The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-t ... Read more >

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Status: Open Not Enrolling

Investigator: Sachin Goel

Study Coordinator: Tia McGaughy

Phone: 346.238.4576

Brief Summary: Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment. In ... Read more >

Cephea Early Feasibility Study

Status: Enrolling

Investigator: Sachin Goel

Study Coordinator: Deena Victor

Phone: 713.441.4536

Brief Summary: The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral regurgitation = Grade III in whom transcatheter therapy i ... 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 >

DiamondTemp System for the Treatment of Persistent Atrial Fibrillation (Diamond-AFII)

Status: Open Not Enrolling

Investigator: Miguel Valderrabano

Study Coordinator: Chinwe Ngumezi

Phone: 713.441.6548

Brief Summary: The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients. Detailed Desc ... 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 >

MitraClip REPAIR MR Study

Status: Enrolling

Investigator: Sachin Goel

Study Coordinator: Tia McGaughy

Phone: 346.238.4576

Brief Summary: 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 ha ... 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 >

The JenaValve ALIGN-AR Pivotal Trial (ALIGN-AR)

Status: Enrolling

Investigator: Michael Reardon

Study Coordinator: Iris Alanis

Phone: 713.441.6548

Brief Summary: To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and ... 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 >

TRILUMINATE Pivotal Trial

Status: Open Not Enrolling

Investigator: Stephen Little

Study Coordinator: Iris Alanis

Phone: 713.441.6548

Brief Summary: 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 ... Read more >

TTVR Early Feasibility Study

Status: Enrolling

Investigator: Sachin Goel

Study Coordinator: Tia McGaughy

Phone: 346.238.4576

Brief Summary: The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expan ... Read more >