ECG Belt for CRT Response (ECG Belt) Save

Date Added
May 19th, 2019
PRO Number
Pro00085400
Researcher
Michael Field

List of Studies

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Keywords
Cardiovascular
Summary

The purpose of this study is to compare the management of CRT device patients using the Medtronic ECG Belt Research System and using routine hospital practice. The participant will be assigned (randomized) to one of 3 study groups. The ECG Belt Research System will be used for data collection at Post-Implant follow-up, 6 months, and 9 months for all groups, in addition to the following:

? Group 1 ? About 200 subjects will be in this group. If participant is in Group 1, he/she will have an ECG Belt guided implant procedure. The ECG Belt Research System will be used to help with the programming of device at Post-Implant follow-up and the 6 month visit.
? Group 2 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at your post-implant follow-up visit. It will be used to help with the programming of device at the 6 month visit.
? Group 3 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at the post-implant follow-up visit and 6-month visit.

The ECG Belt Research System is investigational because it is not approved to be used outside of a study. The experimental procedures in this study are: The ECG Belt guided implant procedure and optimizing CRT settings using the ECG Belt Research System.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA) Save

Date Added
December 11th, 2018
PRO Number
Pro00083402
Researcher
Michael Field

List of Studies

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Keywords
Cardiovascular
Summary

This study is for people who have Paroxysmal Atrial Fibrillation (PAF) and are undergoing an ablation. Atrial fibrillation (AFib) is a type of irregular heartbeat. If you have it, your doctor will classify yours by the reason for it and on how long it lasts. When your heartbeat returns to normal within 7 days, on its own or with treatment, it's known as paroxysmal atrial fibrillation. The purpose of this study is to provide additional information about the safety and effectiveness of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with a THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheter. THERMOCOOL SMARTTOUCH® family of catheters have been approved for the treatment of PAF for people that have unsuccessfully tried antiarrhythmic drug treatment (medication used to correct irregular heart rhythm), due to drug intolerance/side-effects or ineffectiveness of the drugs in preventing PAF. Participation in the study will last approximately 12 months after the ablation procedure. There will be a 7-day phone call and study visits at 1 month, 3-month, 6-month, and 12-months after the ablation procedure to monitor the participant's health and arrhythmia status

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922244
adamsde@musc.edu

A Prospective Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Persistent Atrial Fibrillation Save

Date Added
November 13th, 2018
PRO Number
Pro00083310
Researcher
Michael Field

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. An arrhythmia is a problem with the rate or rhythm of the heartbeat. The purpose of the study is to see whether an investigational medical device called the DiamondTemp Ablation Catheter (also called the DiamondTemp Ablation System) can restore the heart to a normal heart rhythm. Every participant will receive the same treatment, radiofrequency (RF) ablation, for atrial fibrillation with the DiamondTemp Ablation System. The results of this study may be used to help the Food and Drug Administration (FDA) determine if the device should be approved in the USA.

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922944
adamsde@musc.edu

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