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

Pulmonary Hemodynamics during Exercise - Research Network Save

Date Added
May 16th, 2019
PRO Number
Pro00087395
Researcher
Ryan Tedford

List of Studies

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Keywords
Cardiovascular, Heart
Summary

Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PHHFpEF) Save

Date Added
March 25th, 2019
PRO Number
Pro00085482
Researcher
Ryan Tedford

List of Studies

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Keywords
Cardiovascular
Summary

The purpose of this study is to find out if levosimendan is safe and effective in improving symptoms and outcomes for patients with PH-HFpEF.

This study compares an active drug to a placebo. The participant will receive either the active drug, levosimendan, or a placebo via a 24 hour infusion. The study will take place over 6 weeks.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-8300
hinsone@musc.edu

An Open-Label Rollover Study of Levosimendan in Patients with Pulmonary Hypertension with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF) Save

Date Added
March 20th, 2019
PRO Number
Pro00086421
Researcher
Ryan Tedford

List of Studies

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Keywords
Cardiovascular
Summary

The purpose of this study is to find out if levosimendan is safe and effective in improving symptoms and outcomes for patients with PH-HFpEF who have previously participated in the TNX-LVO-04 study. All patients who are enrolled in this study will receive levosimendan weekly through a 24 hour infusion at their home. Office visits will occur at weeks 3, 6, 12, 24, 48, and final visit.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-5935
hinsone@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM Trial) Save

Date Added
March 4th, 2019
PRO Number
Pro00086011
Researcher
Daniel Judge

List of Studies

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Keywords
Cardiovascular, Genetics, Heart
Summary

Amyloidosis (ATTR) Cardiomyopathy (CM) is a progressive, fatal disease in which amyloid deposits build up slowly, over the course of many years to cause organ damage. This study is evaluating the safety and tolerability of a new drug called AG10 administered to adult patients with symptomatic transthyretin amyloid cardiomyopathy. The participant will be randomized to the study drug or placebo and take the study drug two times per day for 30 months.

Institution
MUSC
Recruitment Contact
Anita Smalls
(843) 876-5011
smaani@musc.edu

Safety and Effectiveness of TactiCath Contact Force, Sensor Enabled (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation Save

Date Added
February 12th, 2019
PRO Number
Pro00083338
Researcher
Jeffrey Winterfield

List of Studies

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Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating your symptomatic, persistent atrial fibrillation that is not effectively treated with medication. Participation in the study will last about 15 months from the time of the ablation procedure. Participant will be asked to complete follow-up visits at 7-days (phone call visit only), 3-months, 6-months (phone call), 12-months (phone call or in-person), and 15-months Data collected for this study will be submitted for review and approval by the U.S. Food and Drug Administration (FDA).

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

Multicenter Registry of Chronic Total Occlusion Interventions Save

Date Added
January 3rd, 2019
PRO Number
Pro00083139
Researcher
Anbukarasi Maran

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The study is a purely observational study that will not affect the clinical care of the participating subjects. All patients undergoing CTO PCI at MUSC will be identified and data will be collected on patient characteristics, procedural techniques and clinical outcomes. If the patient returns for follow-up clinical care at MUSC this data will be collected after the visit as well. Anonymized data from each center will be sent to Minneapolis Heart Institute Foundation where they will be combined into a single database and analyzed.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
8437925863
tecklenb@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

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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

The "RADIANCE II" Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension Save

Date Added
October 9th, 2018
PRO Number
Pro00081841
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the FDA. Renal denervation is a procedure where a catheter is placed inside these blood vessels (renal arteries). The ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels.

Participants will stop taking hypertensive medication before the procedure and up to two months after the procedure. Participants will be randomized to the procedure or control and will be followed for 36 months. At the six month follow-up appointment, participants will learn whether they had the procedure or not. Those who did not receive the procedure can opt in to have the procedure in the future.

Institution
MUSC
Recruitment Contact
Vijay Paladugu
8438765009
paladugc@musc.edu

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