Research At CCT

Current Research

Study Title: Cardiovascular Outcomes in Renal Atherosclerotic Lesions Randomized and Multi-Center Two-Group clinical Trial To Assess The Best Treatment for Patients with fligh Blood Pressure and Renal Artery Stenosis: Stenting With Anti-Hypertensive Medical Therapy. Compared to Medical Therapy Alone
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Short Title: Coral

Study Description: This study will enroll patients with a history of systolic hypertension, who have documented renal artery stenosis. Patients will be randomized after angiography to either medical therapy or medical therapy with renal artery stenting and be closely monitored for blood pressure control and management of other risk factors from 3-5 years.

Location:

Baylor Heart and Vascular Hospital
621 N. Hall Ste.400
Dallas, TX. 75226

Lead Principal Investigator: Robert Stoler, M.D., F.A.C.C., F.S.C.A.I.

For further information about this study, please contact: 214-820-9903

Coral Study

Current Research

Study Title: SYNTAX Study: Synergy between PCI with TAXUS™ and Cardiac Surgery. A multicenter, randomized clinical trial comparing TAXUS™ PCI to CABG in patients amenable for revascularization treatment of 3-vesscl disease, left main disease or left main in conjunction with one, two or three vessel disease.
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Short Title: SYNTAX

Study Description: The purpose of the Syntax study is to determine if treatment with drug eluting stents, specifically the Express2™ Paclitaxel-eluting stent (Taxus stent) is as effective as heart surgery in patients with left main disease, patients with multi-vessel disease or left main and multi-vessel disease.

So far the treatment of choice is coronary artery bypass (CABG) surgery, which has been proven to be effective in the long term.

We arc currently trying to assess the value of different treatments - angioplasty or surgery - for the blockages in the right and left side of the heart. Three different groups of patients will be included: in some patients open heart surgery is likely to be the best treatment, in others drug eluting stent angioplasty, while in another group of patients both treatments could be equally effective.

Location:

Baylor Heart and Vascular Hospital
621 N. Hall Ste.400
Dallas, TX. 75226

Lead Principal Investigator: Robert Stoler, M.D., F.A.C.C., F.S.C.A.I.

For further information about this study, please contact: 214-820-9903

SYNTAX Study

Current Research

Study Title: ESTEEM-CRT Study (Evaluation of Screening Techniques in Electrically-Normal, Mechanically-Dyssynchronous Heart Failure Patients Receiving Cardiac Resynchronization Therapy: Multi-centered, feasibility study for patients with narrow QRS who meet other CRT indication.
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Short Title: ESTEEM-CRT

Study Description: This study is being done because we know CRT effectively treats patients with heart failure that have abnormal electrical conduction. We now want to see if CRT is helpful in patients who have heart failure and uncoordinated heart contractions, but are not currently prescribed CRT because they have normal electrical conduction.

Location:

Baylor Heart and Vascular Hospital
621 N. Hall Ste.400
Dallas, TX. 75226

Lead Principal Investigator: Jay O. Franklin, M.D., F.A.C.C.

For further information about this study, please contact: 214-820-3319

ESTEEM-CRT Study

Current Research

Study Title: Holter Monitoring During Exercise and Daily Activity
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Short Title: Holter Monitor Study

Study Description: At the current time defibrillators contain problem-solving computer programs that read electrical activity from the heart to determine if the device needs to pace the heart or shock it back into a normal rhythm. These devices are good at reading the activity, but the muscles in the body also use electricity, which can confuse the signal. This study is trying to determine if there is a better way to process the heart's electrical activity than the problem-solving programs currently being used despite the muscle activity.

Location:

Baylor Heart and Vascular Hospital
62I N. Hall Ste.400
Dallas, TX. 75226

Co Investigator: Jay O. Franklin, M.D., F.A.C.C.

For further information about this study, please contact: 214-820-8819

Holter Monitor Study

Current Research

Study Title: The Prevention of Myocardial Enlargement and Dilatation post Myocardial Infarction Study (MENDMI) and Cardiac CT Substudy: Multi-centered, randomized, feasibility study evaluating the effect of chronic remodeling control therapy in the peri-infarct zone.
_______________________________________________________________

Short Title: MENDMI

Study Description: The purpose of this study is to find out whether pacing the heart directly in the area of a heart attack can decrease the occurrence or severity or congestive heart failure (enlargement of the heart). This study is being conducted to test whether this pacing is safe and beneficial. The therapy (pacing) will be determined to be beneficial if it reduces heart enlargement after a heart attack, in patients who are at high risk of heart enlargement.

This research study is designed to first test the safety of pacing in patients early after a heart attack (within 3-14 days). The second goal of the study is to test whether the pacing is effective. A number of measurements will be taken, but the main test will be for enlargement of the heart.

Location:

Baylor Heart and Vascular Hospital
621 N.Hall Ste.400
Dallas, TX. 75226

Lead Principal Investigator: Jay O. Franklin, M.D., F.A.C.C.

For further information about this study, please contact: 214-820-3319

MENDMI Study

Current Research

Study Title: Attain StarFix Model 4195 Left Ventricular Lead System. Multi-center, non-randomized study to evaluate the safety and effectiveness of the Attain StarFix Model 4195 LV lead.
_______________________________________________________________

Short Title: Model 4195

Study Description: The purpose of this study is to determine if the Model 4195 Lead is safe and effective. The function of the Model 4195 Lead will be studied during the study. The pacemaker, defibrillator and the two right heart leads that are used with the Model 4195 are not investigational leads. This study requires that a Medtronic lead is used for the right ventricle (lower right chamber) and a Medtronic CR device (Pacemaker/Defibrillator). The Medtronic CR device will have the features necessary to fully evaluate the performance of the Model 4195 lead. Because the Model 4195 is an investigational device, this study is regulated and reviewed by the FDA.

Location:

Baylor Heart and Vascular Hospital
62 I N. Hall Ste.400
Dallas, TX. 75226

Lead Principal Investigator: Jay O. Franklin, M.D., F.A.C.C.

For further information about this study, please contact: 214-820-3319

Starfix Study





	Current Research Study Title: Cardiovascular Outcomes in Renal Atherosclerotic Lesions Randomized and Multi-Center Two-Group clinical Trial To Assess The Best Treatment for Patients with fligh Blood Pressure and Renal Artery Stenosis: Stenting With Anti-Hypertensive Medical Therapy. Compared to Medical Therapy Alone _______________________________________________________________ Short Title: Coral Study Description: This study will enroll patients with a history of systolic hypertension, who have documented renal artery stenosis. Patients will be randomized after angiography to either medical therapy or medical therapy with renal artery stenting and be closely monitored for blood pressure control and management of other risk factors from 3-5 years. Location: Baylor Heart and Vascular Hospital 621 N. Hall Ste.400 Dallas, TX. 75226 Lead Principal Investigator: Robert Stoler, M.D., F.A.C.C., F.S.C.A.I. For further information about this study, please contact: 214-820-9903 Coral Study Current Research Study Title: SYNTAX Study: Synergy between PCI with TAXUS™ and Cardiac Surgery. A multicenter, randomized clinical trial comparing TAXUS™ PCI to CABG in patients amenable for revascularization treatment of 3-vesscl disease, left main disease or left main in conjunction with one, two or three vessel disease. _______________________________________________________________ Short Title: SYNTAX Study Description: The purpose of the Syntax study is to determine if treatment with drug eluting stents, specifically the Express2™ Paclitaxel-eluting stent (Taxus stent) is as effective as heart surgery in patients with left main disease, patients with multi-vessel disease or left main and multi-vessel disease. So far the treatment of choice is coronary artery bypass (CABG) surgery, which has been proven to be effective in the long term. We arc currently trying to assess the value of different treatments - angioplasty or surgery - for the blockages in the right and left side of the heart. Three different groups of patients will be included: in some patients open heart surgery is likely to be the best treatment, in others drug eluting stent angioplasty, while in another group of patients both treatments could be equally effective. Location: Baylor Heart and Vascular Hospital 621 N. Hall Ste.400 Dallas, TX. 75226 Lead Principal Investigator: Robert Stoler, M.D., F.A.C.C., F.S.C.A.I. For further information about this study, please contact: 214-820-9903 SYNTAX Study Current Research Study Title: ESTEEM-CRT Study (Evaluation of Screening Techniques in Electrically-Normal, Mechanically-Dyssynchronous Heart Failure Patients Receiving Cardiac Resynchronization Therapy: Multi-centered, feasibility study for patients with narrow QRS who meet other CRT indication. _______________________________________________________________ Short Title: ESTEEM-CRT Study Description: This study is being done because we know CRT effectively treats patients with heart failure that have abnormal electrical conduction. We now want to see if CRT is helpful in patients who have heart failure and uncoordinated heart contractions, but are not currently prescribed CRT because they have normal electrical conduction. Location: Baylor Heart and Vascular Hospital 621 N. Hall Ste.400 Dallas, TX. 75226 Lead Principal Investigator: Jay O. Franklin, M.D., F.A.C.C. For further information about this study, please contact: 214-820-3319 ESTEEM-CRT Study Current Research Study Title: Holter Monitoring During Exercise and Daily Activity _______________________________________________________________ Short Title: Holter Monitor Study Study Description: At the current time defibrillators contain problem-solving computer programs that read electrical activity from the heart to determine if the device needs to pace the heart or shock it back into a normal rhythm. These devices are good at reading the activity, but the muscles in the body also use electricity, which can confuse the signal. This study is trying to determine if there is a better way to process the heart's electrical activity than the problem-solving programs currently being used despite the muscle activity. Location: Baylor Heart and Vascular Hospital 62I N. Hall Ste.400 Dallas, TX. 75226 Co Investigator: Jay O. Franklin, M.D., F.A.C.C. For further information about this study, please contact: 214-820-8819 Holter Monitor Study Current Research Study Title: The Prevention of Myocardial Enlargement and Dilatation post Myocardial Infarction Study (MENDMI) and Cardiac CT Substudy: Multi-centered, randomized, feasibility study evaluating the effect of chronic remodeling control therapy in the peri-infarct zone. _______________________________________________________________ Short Title: MENDMI Study Description: The purpose of this study is to find out whether pacing the heart directly in the area of a heart attack can decrease the occurrence or severity or congestive heart failure (enlargement of the heart). This study is being conducted to test whether this pacing is safe and beneficial. The therapy (pacing) will be determined to be beneficial if it reduces heart enlargement after a heart attack, in patients who are at high risk of heart enlargement. This research study is designed to first test the safety of pacing in patients early after a heart attack (within 3-14 days). The second goal of the study is to test whether the pacing is effective. A number of measurements will be taken, but the main test will be for enlargement of the heart. Location: Baylor Heart and Vascular Hospital 621 N.Hall Ste.400 Dallas, TX. 75226 Lead Principal Investigator: Jay O. Franklin, M.D., F.A.C.C. For further information about this study, please contact: 214-820-3319 MENDMI Study Current Research Study Title: Attain StarFix Model 4195 Left Ventricular Lead System. Multi-center, non-randomized study to evaluate the safety and effectiveness of the Attain StarFix Model 4195 LV lead. _______________________________________________________________ Short Title: Model 4195 Study Description: The purpose of this study is to determine if the Model 4195 Lead is safe and effective. The function of the Model 4195 Lead will be studied during the study. The pacemaker, defibrillator and the two right heart leads that are used with the Model 4195 are not investigational leads. This study requires that a Medtronic lead is used for the right ventricle (lower right chamber) and a Medtronic CR device (Pacemaker/Defibrillator). The Medtronic CR device will have the features necessary to fully evaluate the performance of the Model 4195 lead. Because the Model 4195 is an investigational device, this study is regulated and reviewed by the FDA. Location: Baylor Heart and Vascular Hospital 62 I N. Hall Ste.400 Dallas, TX. 75226 Lead Principal Investigator: Jay O. Franklin, M.D., F.A.C.C. For further information about this study, please contact: 214-820-3319 Starfix Study The information contained in this web site is presented for information purposes only, and is not intended to substitute in any way a consultation with a physician or competent healthcare professional for medical diagnosis and/or treatment.