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Mitral Valve Insufficiency clinical trials

View clinical trials related to Mitral Valve Insufficiency.

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NCT ID: NCT02506387 Recruiting - Clinical trials for Mitral Valve Insufficiency

Belgian Mitraclip Registry

Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

The primary objective of the registry is to investigate and follow all patients treated with the MitraClip System in Belgium. This information is intended to contribute to decision making with regards to MitraClip therapy selection in patients with mitral regurgitation: (a) by establishing the clinical value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers/government in making coverage decisions. In addition national data will be shared with European registries in order to increase the knowledge about the efficacy of this new technique.

NCT ID: NCT02502448 Completed - Clinical trials for Mitral Regurgitation

Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Start date: January 2016
Phase: N/A
Study type: Interventional

Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied. After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.

NCT ID: NCT02478008 Recruiting - Clinical trials for Cardiovascular Disease

A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

NCT ID: NCT02471664 Completed - Heart Failure Clinical Trials

Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

Start date: July 2015
Phase: N/A
Study type: Interventional

To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.

NCT ID: NCT02444338 Completed - Clinical trials for Mitral Valve Insufficiency

A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation

Reshape-HF2
Start date: March 2015
Phase: N/A
Study type: Interventional

To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.

NCT ID: NCT02444286 Withdrawn - Clinical trials for Mitral Valve Insufficiency

The RESHAPE-HF1-FU Study

Start date: January 2017
Phase:
Study type: Observational

To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure.

NCT ID: NCT02432196 Completed - Clinical trials for Mitral Valve Insufficiency

CE Mark Study for the Harpoon Medical Device in Poland

Start date: December 11, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

NCT ID: NCT02428010 Terminated - Clinical trials for Mitral Valve Insufficiency

Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Start date: September 2014
Phase: N/A
Study type: Interventional

Study to evaluate the safety and performance of the Twelve TMVR System

NCT ID: NCT02375282 Completed - Clinical trials for Coronary Artery Disease

Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study

Start date: March 2015
Phase: N/A
Study type: Interventional

Ambulation following surgery has been found to be beneficial for patients; however, nurses and doctors struggle with getting post-operative, hospitalized patients to walk on their own. One promising strategy to address this might be an ambulation orderly, an employee whose single responsibility is to assure that patients walk 3-4 times per day. However, the effect of the ambulation orderly on post-operative physical activity has not yet been described. It is important to quantify what the ambulation orderly does in order to assess if this is an effective method for helping patients walk. As a result, the investigators will perform a pilot randomized controlled trial to test the effects of an ambulation orderly in patients hospitalized with recent cardiac surgery. Half of the patients will be assigned to walk with the ambulation orderly 3-4 times/day and the control group will be given standard nursing encouragement and assistance and encouragement to walk. The investigators will evaluate the average total daily step counts (over the hospital course, usually 4-7 days) and the change in walking distance between a baseline and a final 6 minute walk test. The investigators will also evaluate exercise physiologic parameters (heart rate, oxygen saturation) during ambulation, patient functional independence, and patient satisfaction.

NCT ID: NCT02371863 Completed - Clinical trials for Heart Valve Diseases

Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR

SEP
Start date: December 2014
Phase: N/A
Study type: Observational

Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed. Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.