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Electrophysiology (EP) Research



Research is one of the components that make us unique at the Baptist Heart & Vascular Institute.  Our highly trained staff is dedicated to providing the latest innovations and newest therapies in a community-based setting.  Baptist Health Lexington is working to improve the lives of our patients with heart and vascular disease.

Below is a listing of current electrophysiology (EP) clinical trials:

 

 

IRB 945— Prompt:

Study Title:  Post-MI Remodeling Prevention Therapy

Sponsored by:Medtronic

Status: Closed to enrolment; follow-up in progress

 

Purpose: To investigate the use of cardiac pacing as a method to prevent left ventricular dilation (a precursor for heart failure) after acute myocardial infarction in a select group of patients. The study will include market-approved Biventricular ICD devices in a new population

 

Eligibility:Patients who have had a severe MI in the past 10 days and do not already have an ICD implanted.

 

For additional information, please contact Melody Muir RN, CCRP at 859.260.6429

 

 

IRB 958—RAID:

Study Title: Ranolazine Implantable Cardioverter-Defibrillator Trial

Sponsored by: University of Rochester

Status: Enrolling

 

Purpose:  To see how effective a drug called ranolazine is in reducing the risk of fast cardiac arrhythmias and death in people with an implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications routinely prescribed in enrolled patients.

 

Eligibility: patients with heart disease resulting in a need to have a cardiac defibrillator

 

For additional information, please contact Keri Turner at 859.260.6368

 

 

IRB 993— Analyze ST:

Study Title: ST Monitoring To Detect ACS Events In ICD Patients Study

Sponsored by:St. Jude Medical, Inc

Status: Temporarily closed to enrollment

 

Purpose:  To demonstrate the safety and effectiveness of the ST monitoring feature.  The study will be looking at the sensitivity of the ST Monitoring feature to detect clinical event with a low rate of false alerts.  Device is designed to potentially give patients an early warning sign of a new MI.

 

Eligibility:  Patients who have a history of and MI or coronary artery disease and are indicated for an ICD implant or generator change-out.

 

For additional information, please contact Keri Turner at 859.260.6368

 

 

IRB 1050—CAP2:

Study Title: Continued Access to Prevail (Watchman Left Atrial Appendage Occlusive device)

Sponsored by: Atritech/St. Jude Medical, Inc

Status:   Enrollment closed; FDA approval anticipated near October 2014. Feel free to contact us for more information or to be placed on a waiting list.

 

Purpose: To demonstrate the safety and effectiveness of the Watchman LAA occlusive device in patients with non-valvular AFib.  This is a device alternative to Coumadin for stroke prevention in AFib patients

 

Eligibility: Patients with non-valvular atrial fibrillation with a CHADS2 score of 2 or greater and is eligible to come off of Coumadin.

 

For additional information, please contact Melissa Shepherd, RN at 859.260.4484

 

 

IRB 1071— MultiPoint Pacing (MPP):

Study Title: A Randomized study to evaluate the safety and efficacy of patients treated with MultiPoint Pacing compared to standard Biventricular pacing.

Sponsored by:St. Jude Medical, Inc

Status:  Enrollment closed. Feel free to contact us to discuss other CRT-D study options.

 

Purpose: To evaluate the safety and efficacy of patients treated with MultiPoint Pacing compared to standard Biventricular pacing.

 

Eligibility:  Patient eligible to receive a newly implanted BiVICD

 

For additional information, please contact Melissa Shepherd, RN at 859.260.4484

 

 

IRB 1094— reMARQable (“Remarkable”):

Study Title: nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

Sponsored by:Biosense Webster, Inc

Status:  Enrolling

 

Purpose:  To demonstrate the safety and efficacy a new pulmonary vein ablation catheter that is circular or a crescent shaped, with simultaneous multi-site ablation capabilities in comparison to the traditional single site catheter currently available on the market

 

Eligibility: Patients with symptomatic, paroxysmal atrial fibrillation undergoing a pulmonary vein ablation procedure for the first time and have failed at least one antiarrhythmic drug.

 

For Additional information contact Melody Muir RN, CCRP at 859.260.6429

 

 

IRB 1153—Navigate4 (Nav4):

Title: Evaluation of Acuity X4 Quadripolar Coronary Venous Leads and Reliance™ 4-Front Defibrillation Leads

Sponsored by: Boston Scientific, Inc

Status:  Enrolling

 

Purpose: To establish the safety, performance and effectiveness of the Acuity X4 quadripolar coronary venous leads and the Reliance 4-Front ventricular defibrillation leads

 

Eligibility: Patients who qualify for CRT-D therapy and are de novo implants

 

For additional information, please contact Melissa Shepherd, RN at 859.260.4484

 

 

IRB # 1148—Leadless II:

Title: The Leadless II study

Sponsored by:St. Jude Medical, Inc

Status:  Enrolling

 

Purpose:  To evaluate the safety and effectiveness of the Nanostim Leadless Cardiac Pacemaker System in a patient population indicated for a VVI(R) pacemaker.

 

Eligibility:   Patients who are indicated for a single chamber permanent pacemaker. 

 

For additional information, please contact Keri Turner at 859.260.6368

 

 

IRB# 1156: — FIX-HF-5C: 

Title: Evaluation of the Safety and Efficacy of the OPTIMIZER® System in Subjects with Moderate-to-Severe Heart Failure with Ejection Fraction between 25%and 45%

Sponsored by:Impulse Dynamics

Status:  Enrolling

 

Purpose:   To evaluate the safety and effectiveness of the OPTIMIZER System, using cardiac contractility modulation (CCM) right ventricular pacing therapy in patients with

moderate-to-severe heart failure

 

Eligibility:    Patients with CHF who do not meet criteria for cardiac resynchronization therapy (CRT) secondary to a narrow QRS

 

For additional information, please contact Melody Muir RN, CCRP at 859.260.6429

 

 

IRB# 1161— FIRMAT-PAF:

Title:  Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation

Sponsored by: Topera

Status:   (soon to be) enrolling

 

Purpose:   This is a prospective randomized study to assess the safety and effectiveness of FIRM procedures for the treatment of symptomatic paroxysmal atrial fibrillation.

Hypothesis:  Focal Impulse and Rotor Modulation (FIRM) will substantially reduce or eliminate clinical atrial fibrillation in subjects with accepted indications for catheter ablation of paroxysmal AF, compared to standard pulmonary vein isolation.

 

Eligibility:  patients with documented symptomatic paroxysmal atrial fibrillation undergoing a standard of care cardiac ablation for atrial fibrillation.

 

For additional information, please contact Melody Muir RN, CCRP at 859.260.6429

 

 

IRB # 1181—Enhance CRT:

Title: CRT Implant Strategy Using the Longest Electrical Delay for Non-Left Bundle Branch Block Patients

Sponsored by:St. Jude Medical, Inc

Status:  (Soon to be) enrolling

 

Purpose: to analyze the effect of LV lead pacing location (guided via QLV measurement vs. standard of care approach) in the non-LBBB HF patient population.

 

Main Eligibility: patients with non-LBBB  pattern with QRS duration ≥ 120 ms, LVEF ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, and NYHA class III/ambulatory class IV on guideline directed medical therapy

 

For additional information, please contact Keri Turner at 859.260.6368