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 761 Determine- Randomized Trial:
Defibrillators to Reduce Risk by Magnetic Resonance Imaging Evaluation
Purpose: To evaluate whether therapy with an ICD combined with medical therapy improves long-term survival compared to medical therapy alone in patients with CAD, infarct mass greater than or equal to 10% and LV dysfunction who do not otherwise have criteria for ICD implantation.
Eligibility: Patients who have a history of MI or systolic left ventricular dysfunction, a preliminary EF >35% and have undergone a CE-MRI.
For additional information, please contact Melody Muir at 859-260-6429.
IRB 887 ThermoCool PAF:
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation – Post Approval Registry. Protocol # P030031/S014.
Purpose: To provide information about possible short and long term complications of the NaviStar® ThermoCool® catheters used to treat symptomatic paroxysmal atrial fibrillation.
Eligibility: Subjects who have had at least 3 episodes of symptomatic PAF in the last 6 month period, one of which is documented, and failure of at least 1 anti-arrhythmic drug.
For additional information, please contact Jennifer Isaacs at 859-260-6368.
IRB 898 Duo Flair:
Clinical Evaluation Therapy TM Cool Path™ Duo Cardiac Ablation System For the Treatment of Typical Atrial Flutter
Purpose: The purpose of this study is to demonstrate the safety and efficacy of Therapy™ Cool Path™ Duo catheter ablation system for the treatment of typical atrial flutter. The study is aimed at demonstrating the equivalence between the Therapy™ CoolPath™ Duo catheter ablation system and FDA approved Therapy™ Cool Path™ Catheter ablation system.
Eligibility: Patients must present with typical atrial flutter (cavotricuspid isthmus dependent), receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter. Then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.
One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months. Patient must be in good physical health.
For additional information, please contact Melissa Franklin at 859-260-4484.
IRB 917 MultiSENSE:
Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE)
Purpose: The purpose of the MultiSENSE study is to collect chronic ambulatory data simultaneously from multiple sensors in CRT-D devices in order to develop algorithms for the early detection of worsening heart failure.
Eligibility: Patients who have been implanted with the Boston Scientific COGNIS CRT-D device who have experienced a heart failure event as defined by the protocol within the previous 6 months or 2 in the previous 12 months.
For additional information, please contact Melissa Franklin at 859-260-4484.
IRB 925 EchoCRT:
Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation
Purpose: The purpose of the EchoCRT study is to determine if Cardiac Resynchronization Therapy in patients with heart failure, narrow QRS, and ventricular dyssynchrony will reduce mortality or hospitalizations for heart failure.
Eligibility: Heart failure subjects with an ICD indication, NYHA class III-IV, narrow QRS <130ms and ventricular dyssynchrony.
For additional information, please contact Melody Muir at 859-260-6429.
IRB 928 PREVAIL:
Prospective Randomized Evaluation of the Watchman LAA (Left Atrial Appendage) Closure Device In Patients with Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)
Purpose: Implantable cardiac device alternative to chronic coumadin therapy for embolic event protection in AF patients. Patients will be randomized to receive either the Watchman LAA Closure device or coumadin therapy.
Eligibility: Patients with non-valvular AF and are eligible for long-term coumadin therapy.
For additional information, please contact Jennifer Isaacs at 859-260-6368.
IRB# 952: CABANA:
Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
The CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF).
Purpose: The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for reducing total mortality in patients with untreated or incompletely treated AF.
For additional information, please contact Melissa Franklin at 859-260-4484.
IRB# 958: RAID:
Ranolazine Implantable Cardioverter-Defibrillator Trial
Purpose: To see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications routinely prescribed in enrolled patients.
For additional information, please contact Melissa Franklin at 859-260-4484.