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Heart Valve Diseases clinical trials

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NCT ID: NCT01116037 Terminated - Clinical trials for Heart Valve Diseases

ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

PAS
Start date: September 2009
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

NCT ID: NCT00705913 Terminated - Clinical trials for Aortic Valve Disease

Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Start date: June 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.

NCT ID: NCT00700947 Terminated - Heart Disease Clinical Trials

Using Beta Blockers to Treat Mitral Regurgitation

REGURG
Start date: October 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.

NCT ID: NCT00657826 Terminated - Clinical trials for Heart Valve Diseases

ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm

Start date: October 2001
Phase: N/A
Study type: Interventional

The initial clinical investigation titled "ATS 3f(r) Aortic Bioprosthesis Model 1000 Study," was a prospective, non-randomized, multi-center study designed to evaluate the the safety and effectiveness obtained from 800 patient years using a common clinical protocol. Twenty-three (23) sites internationally and in the United States combined enrolled 405 patients. The objective of the study was to evaluate the safety and effectiveness of the ATS 3f(r) Aortic Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient population undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis with or without concomitant procedures. Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE was expanded to comply with the conditions set forth in the approval notice. Study Protocol S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as "A multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled patient will be followed for a minimum one year and annually thereafter until size 19mm product approval or study cessation. Preoperative, discharge or 30 days (which ever comes last), 3-6 month, and annual follow-up data are required.

NCT ID: NCT00619151 Terminated - Clinical trials for Aortic Valve Disease

CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

Start date: December 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

NCT ID: NCT00598936 Terminated - Clinical trials for Coronary Artery Disease

A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients

Start date: November 2007
Phase: Phase 1
Study type: Observational

The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.

NCT ID: NCT00590889 Terminated - Clinical trials for Aortic Valve Disease

Artificial Valve Endocarditis Reduction Trial

AVERT
Start date: July 1998
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

NCT ID: NCT00250965 Terminated - Clinical trials for Coronary Artery Disease

MPAACS: Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery

Start date: July 2004
Phase: Phase 3
Study type: Interventional

The objective of our research is to determine whether treatment with magnesium will reduce the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small studies of magnesium have already been conducted, but these studies were small and the results conflicting. A large, well-conducted study of magnesium treatment is required to definitively determine whether magnesium is effective in preventing this common complication after surgery. In addition, our study will include patients undergoing valvular surgery, a group previously excluded from research despite the fact that they are at increased risk of atrial fibrillation.

NCT ID: NCT00221663 Terminated - Clinical trials for Heart Valve Diseases

Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Start date: January 2002
Phase: Phase 2/Phase 3
Study type: Interventional

Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.

NCT ID: NCT00107666 Terminated - Coronary Disease Clinical Trials

CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)

Start date: April 2005
Phase: Phase 2
Study type: Interventional

Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction. The incidence of complications may exceed 30%. It has been speculated that an exaggerated inflammatory response to surgical trauma and the CPB machine are likely causes for this morbidity. Factors predisposing organ dysfunction include tissue injury, endotoxemia, and oxidative stress. High risk patients can be identified preoperatively through the validated Parsonnet Additive Risk Score. CTI-01 has demonstrated potent anti-inflammatory and tissue protection activity in multiple animal models of disease including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. These findings support its clinical use in critical care medicine including cardiac surgery. Patients will receive a total of six doses, administered intravenously just prior to and after surgery.