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Cardiology Clinical Trials

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Explore our current clinical trials for cardiology:

[Updated: 4/18/2018]

Electrophysiology 

LSS of 4SITE Study

The goal of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-SITE Lead/Header System.

Optimum Registry

This registry will evaluate the chronic clinical performance of the market-released SJM Cardiac Rhythm Management (CRM) leads with Optimum insulation material. 

AMPLATZER™ AMULET™ Left Atrial Appendage (LAA) Occluder Trial

The  AMPLATZER™ Amulet™  Left Atrial Appendage (LAA) Occluder Trial is designed to evaluate the safety and effectiveness of the Amulet device compared to the approved WATCHMAN LAA closure device in patients with non-valvular atrial fibrillation and at a high risk for bleeding.   Eligible patients will be randomized to receive wither the Amulet device or the WATCHMAN device.

Smart Registry

A registry to learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

Heart Failure

CONNECT HF

A large scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of 2 quality improvement (QI) initiatives compared with usual care on heart failure (HF) outcomes and HF quality of care metrics at 1 year after discharge for participants hospitalized with acute HF and reduced ejection fraction (EF). 

Interventional

Absorb III & IV

A prospective randomized, single-blind, multi-center trial to evaluate the safety and effectiveness of the Absorb BVS System compared to XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

Harmonee Study

A multi-center, single-blind, randomized, Clinical Evaluation of the Combination Sirolimus-Eluting and anti-CD34 Antibody-Coated (COMBO) Stent for Coronary Lesions.  

Leaders Free II BioFreedon Pivotal Study

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study in high bleeding risk patients.

Xience Short DAPT

A prospective, multicenter, single-arm study designed to assess   the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding undergoing percutaneous coronary intervention with any approved XIENCE family of Stent Systems. 

Eclipse Study

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

Interventional/Peripheral Vascular

Disrupt PAD III

A multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries.

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