TCAVI Research Foundation

Atrial Fibrillation

Artesia (Enrolling)

The purpose of the study is to determine which treatment, apixaban or aspirin, is best for preventing stroke or systemic embolism in patients who have > 1 episode of sub-clinical atrial fibrillation (SCAF) detected by pacemaker or ICD or ICM and also have other risk factors for stroke.

Coronary Artery Disease

DAL-GENE (FOLLOW-UP)

The double-blind, randomized, placebo-controlled, multicenter Phase 3 clinical trial will enroll 5,000 patients recently hospitalized with ACS and who express the AA genotype at variant rs1967309 in the ADCY9 gene, determined by an investigational companion diagnostic test developed by Roche Molecular Systems (RMS). The primary endpoint of the study is the time to first occurrence of any component of the composite of cardiovascular death, myocardial infarction (heart attack) and stroke. The trial will be conducted at 1,000 sites in 33 countries.

ECLIPSE (ENROLLING)

The purpose of this trial is to evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES). This is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with Orbital Atherectomy (OA) compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions.

EVOLVE SHORT DAPT (FOLLOW-UP)

The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent System.

ILUMIEN IV (ENROLLING)

The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

NATIONAL CARDIOGENIC SHOCK INITIATIVE (NCSI) (ENROLLING)

This study evaluates the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic Shock registry.

XIENCE 90 (FOLLOW-UP)

XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents.

Heart Failure

APPRAISE ATP (ENROLLING)

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

ADAPT RESPONSE (FOLLOW-UP)

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

BMAD HF (ENROLLING)

To identify correlations between µCor measurements (thoracic fluid index, cardiac rhythm, respiration rate, physical activity, and posture) with occurrences of heart failure related clinical events occurring within 90 days of hospital discharge for acute decompensated heart failure.

Hypertension

RADIANCE-HTN (FOLLOW-UP)

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

See if you qualify http://highbptrial.com/

RADIANCE II (ENROLLING)

The objective of the Radiance II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System (renal denervation) in subjects with Stage 2 hypertension on 0-2 medications at the time of consent.

See if you qualify http://highbptrial.com/

Peripheral Artery Disease

ZILVER PTX (FOLLOW-UP)

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

CHOCOLATE TOUCH (FOLLOW-UP)

The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States.

FAST II (ENROLLING)

To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

LEVANT BTK (FOLLOW-UP)

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

PROMISE II (ENROLLING)

The objective of this US pivotal trial is to investigate the safety and effectiveness of The LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia (CLTI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

TORUS2 (ENROLLING)

The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.

Structural Heart

APOLLO (ENROLLING)

Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) -two subject groups: the randomized group will be randomized on 1:1 basis either to the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device.

CLASP IID/IIF (ENROLLING)

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).

EARLYTAVR (ENROLLING)

Patients with asymptomatic, severe Aortic Valve Disease will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test.

REPRISE IV (ENROLLING)

To evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.