Research Protocol Synopsis

Registries

Registries are Phase IV clinical trials that take place after a device or procedure has been FDA approved in order to ensure that the device/procedure is still safe in a larger patient population. These trials do not deviate from standard of care. Patients will not attend any extra clinic visit and do not require any additional procedures.

Product Surveillance Registry (PSR)

The Product Surveillance Registry is a cardiac device registry with Medtronic. Eligibility for this trial is dependent on which device is implanted into a patient. Currently we are enrolling patients with certain Medtronic leads, as well as patients receiving CRT (cardiac resynchronization therapy) devices who meet specific medical criteria. Data collected in this study will be analyzed by Medtronic and used to produce better devices.

Longitudinal Surveillance Registry (LSR)

The Longitudinal Surveillance Registry is a registry for Boston Scientific's Acuity Spiral Lead. Similar to PSR, this study is used to monitor continued safety for the device. Data collected will be used to produce better products.

SICD-Post Approval Study

The SICD-PAS study is a Boston Scientific study for the Subcutaneous ICD device. Any patient planning to have an SICD implanted is eligible for the study if they are eligible for the device. Enrollment for this study has recently opened. This study is collecting data on the device to help improve the future devices, as well as ensure continued device safety.

Interventional Trials

Interventional trials are those trials which have an investigational procedure or device. They often have clinicians conduct procedures or use devices that are not standard of care in order to prove safety and efficacy in a large patient population (above 100 patients).

These trials are usually funded by large companies looking to gather data to prove their device is safe and efficacious. Because of their investigational nature, some trials will pay for procedures that are not considered standard in the medical industry. Despite being experimental in nature, the trials at EP Heart have already passed efficacy and safety trials in smaller patient populations (below 100 patients). These trials are the final step in a device seeking FDA approval.

Zero AF

Zero AF is a Boston Scientific clinical trial for the Blazer Open Irrigated Ablation Catheter in the use of atrial fibrillation ablation. The trial compares a control catheter versus the Blazer investigational catheter. This study is randomized, and as such, approximately half of patients enrolled will receive the investigational catheter. All patients involved in this study must undergo procedure at Memorial Hermann - Texas Medical Center. The patient must meet stringent inclusion/exclusion criteria in order to be enrolled in this trial. EP Heart is currently the #1 enrolling site worldwide with more than 35 patients enrolled. The data collected in this study will be used to seek FDA approval of the device, as well as guide Boston Scientific in the production of its next generation devices. Talk to your physician to determine if you are eligible and if participation in this trial is appropriate.

Navigate

Navigate is a Boston Scientific clinical trial for the ACUITY X4 Quadripolar Coronary Venous Leads, as well as the RELIANCE 4-FRONT Ventricular Defibrillation Leads. The patient must meet stringent inclusion/exclusion criteria. Patients enrolled in the Navigate study can undergo procedure at Memorial Hermann - Texas Medical Center, Memorial Hermann Southeast, and Memorial Hermann The Woodlands. EP Heart is currently in the top 15 enrolling sites worldwide. This study is not randomized – all patients who enroll will receive the investigational leads. The data collected in this study will be used to seek FDA approval of the investigational devices. Talk to your physician to determine if you are eligible and if participation in this trial is appropriate.

Leadless II 

The Leadless II study is a clinical trial for St. Jude's leadless single chamber pacemaker. The procedure and device are approved at Memorial Hermann The Woodlands, Memorial Hermann - Texas Medical Center, and Memorial Hermann Memorial City. The device is comparable in many ways to a traditional pacemaker. It has a comparable battery life and offers similar diagnostic software that can be interpreted by your physician. The difference between this device and a traditional pacemaker is that this pacemaker is implanted directly into your heart. This can prevent complications from dislodged leads and infection. It also avoids the typical “bump” under your skin where the traditional device is implanted. The data collected in this trial will be used to seek FDA approval of the Leadless II Pacemaker, as well as help to improve upon the design of future pacemakers Talk to your physician to determine if you are eligible and if participation in this trial is appropriate.

Inovate-HF

The Inovate-HF study is a device study testing the safety and efficacy of BioControl Medical's CardioFit system. The system is a novel device used to stimulate the vagus nerve in coordination with ventricular contraction. The idea behind the system is to increase vagal tone to lower heart rate. It is hypothesized that the lower heart rate will decrease burden on the heart and provide relief from symptoms and encourage heart remodeling. Preliminary studies have demonstrated a positive effect and the device may improve the conditions of patients living with advanced heart failure.

AdaptResponse 

The AdaptResponse clinical trial is a study by Medtronic to determine if the AdaptResponse algorithm provides a more positive outcome for patients than standard Bi-Ventricular pacing. Patients enrolled in the study must agree to have an AdaptResponse ready Medtronic Bi-V Pacemaker or ICD implanted. Patients are randomized 1:1 to AdaptResponse on or AdaptResponse off. Patients must meet inclusion/exclusion requirements to be included. There are no investigational products being used in this study. All parts and equipment are FDA approved. Talk to your physician to determine if you are eligible and if participation in this trial is appropriate.

STAR-VT

This study is a complex interventional study by St. Jude Medical designed to determine the effectiveness of Ventricular Tachycardia Ablation to minimize the occurence of ICD Shock with standard drug therapy versus standard drug therapy alone. It is hypothesized that if patients have an ablation prior to the first ICD shock, the patient is either less likely to experience a rhythm that requires a shock, or the time to first shock will be much greater than if the patient did not receive the ablation. The study uses the FlexAbility catheter and is targeting patients that exhibit a certain heart rhythm called “monomorphic VT”. The patient must meet stringent inclusion/exclusion criteria to be enrolled. Talk to your physician to determine if you are eligible and if participation in this trial is appropriate.

Smart-SF

This study is an interventional study designed to demonstrate the safety of the Thermocool SmartTouch SF catheters in the treatmnt of refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures. The ablation catheter is a new catheter being brought to market that combines thermocool technology with SmartTouch technology. Ablation with this catheter may offer certain advantages for your physician. Talk to your physician to determine if you are eligible and if participation in this trial is appropriate.

WRAP-IT

Status: Not yet enrolling

This study is an interventional study for patients receiving a Bi-ventricular ICD for the first time, or an upgrade/replacement of a currently implanted IPG/ICD. The WRAP-IT will test the effectiveness of the TYRX envelope to reduce major infection around the area that the device is implanted. The patient must meet inclusion/exclusion to participate in this study. Talk to your physician to determine if you are eligible and if participation in this trial is appropriate.