Interventional Valvular Heart Disease Research

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR

Summary: ACURATE IDE is a prospective, multicenter trial designed to evaluate the safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for TAVR in subjects who have severe native aortic stenosis and are indicated for TAVR.

• Primary Investigator: Ignacio Inglessis, MD
• Study Population or Disease Focus: Patients with documented severe symptomatic native aortic stenosis who are at intermediate risk or above for surgical valve replacement.
• Status: Enrolling
• Source: Industry-initiated

The APOLLO Trial: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation.

Summary: The APOLLO trial aims to help patients with heart failure who have leaky mitral valves that do no close properly. The study involves a procedure that replaces the leaky mitral valve with a bioprosthetic valve to help improve heart function and alleviate heart failure symptoms. The procedure is done using a trans-apical approach, meaning the valve is implanted through a small incision between a patient's ribs. This method of surgery is less invasive than full open-heart surgery.

• Primary Investigators: Ignacio Inglessis, MD and Serguei Melnitchouk, MD, MPH
• Study Population or Disease Focus: Patients with moderate to severe or severe mitral regurgitation
• Status: Enrolling
• Source: Industry-initiated

The CARILLON Study: Assessment of the CARILLON® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated with Heart Failure

Summary: The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with heart failure.

• Primary Investigator: Igor Palacios, MD
• Study Population or Disease Focus: Symptomatic patients with moderate to severe mitral regurgitation
  • Status: Enrolling
• Source: Industry-initiated

CLASP II TR Pivotal Clinical Trial: Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical 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

Summary: The CLASP II TR Trial focusses on the deployment of a small, implantable clip in patients experiencing severe tricuspid regurgitation. This clip is designed to realign, stabilize and fasten the leaflettes of the tricuspid valve, reducing the symptoms of tricuspid regurgitation as a result.

• Primary Investigators: Sammy Elmariah, MD and Ignacio Inglessis, MD
• Study Population or Disease Focus: Tricuspid valve regurgitation
• Status: Enrolling
• Source: Industry-initiated

CLASP IID/IIF: 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.

Summary: The CLASP IID/IIF study focuses on patients with heart failure who have leaky mitral valves that do not close properly. The study offers patients a procedure using a clip device that grabs onto the leaflets of the mitral valve to stabilize and realign them so that the valve becomes less leaky. In turn, patients typically experience improved heart function and alleviation of their heart failure symptoms. The procedure is done using catheters that are fed into the heart through vessels in the groin, which is a less invasive approach than open-heart surgery.

• Primary Investigator: Ignacio Inglessis, MD
• Study Population or Disease Focus: Patients with moderate to severe or severe mitral regurgitation
• Status: Enrolling
• Source: Industry-sponsored

DISCORDANCE TAVR: Standardized Invasive Hemodynamics for Monitoring Acute and Long-Term Valve Performance in Patients with Elevated Gradients Post Transcatheter Aortic Valve Replacement

Summary: This study will compare the discordance between echocardiography-derived gradients and invasive transaortic gradients post-TAVR to determine the most effective way to monitoring acute and long-term valve performance post TAVR in patients with elevated gradients.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients with elevated gradients post TAVR
• Status: Enrolling

ENCIRCLE: SAPIEN M3 System Transcatheter Mitral Valve Replacement via Transseptal Access

Summary: This trial aims to bring treatment to patients with symptomatic mitral regurgitation who are deemed unsuitable for commercially available surgical or transcatheter treatment options. This study will establish the safety and effectiveness of the SAPIEN M3 System.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients with symptomatic mitral regurgitation (MR) for whom commercially available treatment options are deemed unsuitable.
• Status: Enrolling
• Source: Industry-initiated

The HALT Biomarker Study: Circulating Biomarkers of Hypo-Attenuated Leaflet Thickening after Transcatheter Aortic Valve Replacement

Summary: The purpose of this study is to develop a diagnostic blood test for a condition called HALT, which can currently only be diagnosed with a CT scan. HALT occurs when tiny blood clots form on the prosthetic valve, which may affect valve durability or put patients at greater risk of stroke. 

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients with aortic stenosis or bioprosthetic valve degeneration undergoing TAVR with an Evolut valve and not on anticoagulants
• Status: Enrolling
• Source: PI-initiated

Low Risk Bicuspid: TAVR with Medtronic TAVR System in Patients with Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality with SAVR Clinical Investigation Plan

Summary: The objective of the Low Risk Bicuspid study is to help patients with bicuspid aortic valves who suffer from heart failure due to aortic stenosis. The study involves a procedure to replace a patient's diseased aortic valve with a bioprosthetic valve that helps improve heart function. Using catheters that are fed into the heart from vessels in the groin, the procedure provides a less invasive approach to valve replacement than open-heart surgery.

• Primary Investigator: Ignacio Inglessis, MD
• Study Population or Disease Focus: Patients with bicuspid aortic valves and severe aortic stenosis that are at low risk for surgery
• Status: FU only
• Source: Industry-sponsored

PORTICO Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Summary: The primary objective of this trial is to determine the safety and effectiveness of the Portico Transcatheter Heart Valve and Delivery systems (Portico) via transfemoral and alternative delivery methods in high and extreme risk cohorts. The hypothesis being tested is that treatment with the SJM Portico device delivered through a transfemoral, or alternative access route is non-inferior to the control group in high risk or inoperable patients.

• Primary Investigator: Ignacio Inglessis, MD
• Study Population or Disease Focus: Patients with severe aortic stenosis who are high-risk and extreme-risk for surgical valve replacement.
• Status: Follow-up only
• Source: Industry-initiated

PROTECTED TAVR: Stroke Protection with Sentinel During Transcatheter Aortic Valve Replacement

Summary: The objective of this study is to demonstrate that use of the Sentinel Cerebral Protection System significantly reduces the risk of periprocedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

• Primary Investigator: Rahul Sakhuja, MD
• Study Population or Disease Focus: Subjects with aortic valve stenosis undergoing TAVR
• Status: Closed to enrollment
• Source: Industry-initiated

REPAIR MR: Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery

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 has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Symptomatic patients with moderate to severe mitral regurgitation
• Status: Enrolling
• Source: Industry-initiated

TAVR Low-Risk: Transcatheter Aortic Valve Replacement with the Medtronic Transcatheter Aortic Valve Replacement System in Patients at Low Risk for Surgical Aortic Valve Replacement

Summary: The primary objective of this study is to evaluate the safety and effectiveness of the Medtronic Transcatheter Aortic Valve Replacement system (Corevalve system and Evolut R system) in patients who are at low predicted risk for mortality at 30 days with surgical aortic valve replacement (SAVR).

• Primary Investigators: Ignacio Inglessis, MD and Serguei Melnitchouk, MD, MPH
• Study Population or Disease Focus: Patients with severe aortic stenosis with a clinical indication for surgical aortic valve replacement with a bioprosthesis who are at low predicted risk of mortality at 30 days for surgical aortic valve replacement
• Status: Follow-up only
• Source: Industry-initiated

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Advanced heart failure
• Status: Enrolling
• Source: Industry-initiated

TRISCEND: Edwards Transcatheter Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy Using a Novel Device

Summary: The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients with tricuspid valve regurgitation undergoing valve repair
• Status: Follow-up only
• Source: Industry-initiated

TRISCEND II: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

Summary: The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients with tricuspid valve regurgitation
• Status: Enrolling
• Source: Industry-initiated

AS Biomarkers: Novel Biomarkers of Aortic Stenosis Trial

Summary: The purpose of this study is to develop a better understanding of the pathophysiology and progression of aortic stenosis (AS) and thus improve treatment. This is being accomplished by longitudinally following patients from the time that their moderate AS is diagnosed through a year after transcatheter or surgical intervention.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients with at least moderate aortic stenosis (AS)
• Status: Enrolling
• Source: PI-initiated

DETECT AS: Electronic Physician Notification to Facilitate the Recognition and Management of Sever Aortic Stenosis

Summary: This randomized clinical trial and quality improvement initiative seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization of aortic valve replacement (AVR), and on ethnic and racial disparities in AVR utilization.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients with recent Echocardiographs showing serve aortic stenosis
• Status: Enrolling
• Source: PI-initiated

Summary: National registry of diagnostic and interventional procedures in children and adults with congenital heart disease

• Primary Investigator: Ada Stefanescu, MD MSc
• Study Population: Adults with congenital heart disease undergoing catheter-based procedures
• Status: Enrolling
• Source: American College of Cardiology National Cardiovascular Data Registry

MR/TR Metabolomics: Prediction Models for Outcomes after Transcatheter Mitral or Tricuspid Valve Interventions

Summary: The purpose of this study is to evaluate biomarkers in patient blood samples, before and after mitral or tricuspid valve intervention, in order to predict which patients will benefit most from intervention.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients undergoing mitral or tricuspid valve repair or replacement
• Status: Enrolling
• Source: PI-initiated

Summary: National registry of self-expanding transcatheter pulmonary valve implantation in patients with congenital heart disease with large right ventricular outflow tracts

• Primary Investigator: Ada Stefanescu, MD MSc
• Study Population: Adults with congenital right ventricular outflow tract disease and pulmonary regurgitation
• Status: Enrolling
• Source: Investigator-initiated

T-ViV Registry: Transcatheter Tricuspid Valve Replacement for Failed Surgical Prosthesis: A Multi-Center Registry Using Sapien 3 Valve

Summary: This study is a U.S. multi-center, retrospective registry-based study of patients who have undergone Transcatheter Tricuspid Valve Replacement (TTVR) using contemporary balloon expandable to treat failed or degenerated surgically placed bioprosthetic valve (Tricuspid Valve-in-Valve).

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Patients who have undergone a valve-in-valve procedure using the Sapien 3 valve
• Status: Data collection