Valley Heart & Vascular Institute - Clinical Trials
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Electrophysiology Trials

AMAZE

“Left Atrial Appendage Ligation With The Lariat+® Suture Delivery System As Adjunctive Therapy To Pulmonary Vein Isolation For Persistent Or Longstanding Persistent Atrial Fibrillation”

Study Objective: The objective of this study is evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

Eligibility: Patients may be eligible for this study if they are 18 and 80 years of age, with a diagnosis of symptomatic persistent or longstanding persistent AF who have failed at least one Class I or III AAD, and no prior epicardial or endocardial AF ablation procedure.

Arm A: Closing the left atrial appendage with the LARIAT procedure, followed by catheter ablation

Arm B: Catheter ablation only

**The LARIAT procedure is currently cleared by the United States Food and Drug Administration for use in general surgery but has not been well-studied for closing the LAA in Afib patients also receiving catheter ablation. Therefore, it is investigational for this specific purpose. Clinical studies of the LARIAT and similar devices suggest it may help reduce the recurrence of Afib.

Principal Investigator: Dan Musat, MD

Click here for more information on AMAZE


MEDTRONIC PSR

“Medtronic Product Surveillance Registry”

Study Objective: The objective of this registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Eligibility: Participants legally authorized representative provides written authorization and/or consent per institution and geographical requirements, patient has or is intended to receive or be treated with an eligible Medtronic product, patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Principal Investigator: Suneet Mittal, MD

Click here for more information on MEDTRONIC PSR


SIMPLICITY AF

“Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation”

Study Objective: The objective of this study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension.

Eligibility: Participants must be drug refractory recurrent symptomatic paroxysmal or persistent atrial fibrillation, office-based systolic blood pressure of ≥150 mm Hg based despite treatment with 2 or more antihypertensive medications of different classes (one of these must be a diuretic).

Principal Investigator: Suneet Mittal, MD

Click here for more information on SIMPLICITY AF


ENVELOPE

“Randomized Noninferiority Study of the TYRX-A Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Oral Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients.”

Study Objective: To test the hypothesis that the use of the TYRX antibacterial envelope alone is noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device infections in patients with ≥2 risk factors for infection.

Eligibility: Scheduled to undergo a procedure to receive a pacemaker or implantable cardioverter-defibrillator (ICD) device or have previously received a pacemaker or ICD device which will need to be changed or replaced.

Principal Investigator:Suneet Mittal, MD


DECAAF II

“Efficacy of DE-MRI-Guided Fibrosis Ablation vs. Conventional Catheter Ablation of Atrial Fibrillation.”

Study Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF.

Eligibility: A diagnosis with atrial fibrillation (AF) and are scheduled or will be scheduled to have an AF ablation procedure.

Principal Investigator:Suneet Mittal, MD


ARTESIA

“Apixaban for the reduction of thrombo-embolism in patients with device-detected sub-clinical atrial fibrillation.”

Study Objective: To determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.

Eligibility: Pacemaker or intracardiac defibrillator (ICD) or insertable cardiac monitor (ICM) and your device has detected at least one episode of an abnormal heart rhythm known as sub-clinical atrial fibrillation (SCAF).

Principal Investigator:Suneet Mittal, MD


RHAPSODY

“Rhythmia mAPping and Signal acquisitiOn for Data analysis.”

Study Objective: To evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.

Eligibility: Scheduled for a procedure to evaluate and treat your irregular heart rhythms, a procedure known as an ablation procedure or an electrophysiology procedure.

Principal Investigator:Suneet Mittal, MD


DRESSLER’S SYNDROME

“Anti-heart antibodies as predictors for the development of Dressler’s Syndrome post hybrid ablation (AHA-DSHA).”

Study Objective: The blood specimens that you donate will be used in studies designed to help us better understand the causes of Dressler’s Syndrome and other cardiovascular disease process after a hybrid ablation.

Eligibility: Diagnosis of atrial fibrillation and are having a hybrid ablation.

Principal Investigator:Tina Sichrovsky, MD

 
 
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