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Heart Septal Defects clinical trials

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NCT ID: NCT03363932 Active, not recruiting - Clinical trials for Congenital Heart Disease

French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

FRANCISCO
Start date: June 1, 2018
Phase:
Study type: Observational

Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude. The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are: - To study the incidence of cardiovascular events in perimembranous VSD and search for predictive anatomical markers of events. - To study the evolution of echocardiographic and functional data of patients having percutaneous or surgical closure compared to patient managed medically. This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.

NCT ID: NCT03127748 Recruiting - Clinical trials for Ventricular Septal Defect

Cardiac Function After Transcatheter VSD Closure

Start date: July 1, 2015
Phase: N/A
Study type: Observational

With advances in interventional cardiac catheterization, ventricular septal defect (VSD) could be successfully treated via transcatheter device closure. Cardiac catheterization team of National Taiwan University Children's Hospital has recently treated more than 60 patients with VSD using this technique. Both treatment effect and follow-up results were encouraging. Of particular notice is that many patients experienced subjective improvement in exercise tolerance after VSD closure. Traditionally, VSD could only be repaired by open-heart surgery under cardiopulmonary bypass. Therefore, VSD closure would be considered only for those with moderate to large defect, significant heart failure, or presenting with significant exercise intolerance. With the success in transcatheter closure of VSD, a procedure which is safer and leading to faster recovery comparing to cardiac surgery, device closure of VSD would be a reasonable and sensible treatment of choice if it is beneficial for long-term cardiac function and exercise performance. This project will prospectively enroll 50 patients with VSDs subject to transcatheter closure of the defect in our institute. Before device closure and 6 months after closure, participants will be assessed with image studies (including speckle tracking and tissue Doppler echocardiography), measurements of serum biomarkers (including B-type natriuretic peptide and biomarkers of collagen metabolism), and standard cardiopulmonary exercise test. The purpose of this study is to investigate the potential benefits of closing VSD with respect to cardiac function and exercise performance, which might serve as basis to redefine future indication of VSD closure.

NCT ID: NCT03024268 Active, not recruiting - Clinical trials for Mitral Valve Insufficiency

MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure

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

Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.

NCT ID: NCT02985684 Completed - Clinical trials for Atrial Septal Defect

Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs

ASSURED
Start date: March 10, 2017
Phase: N/A
Study type: Interventional

Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)

NCT ID: NCT02957201 Completed - Clinical trials for Atrial Septal Defect

The Effect on EPCs by Successful Cardiac Occlusion Device Implantation

EPIC
Start date: July 2016
Phase: N/A
Study type: Interventional

All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be identified and reviewed in cardiology clinics. These patients will be placed on waiting list to undergo the procedure. Patient-participants will be consented on the date of admission for device closure implantation. The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and 10 patients undergoing LAA closure. EPC will be measured on the day of the device implantation, day 0 and prior to discharge on day 1. Patient participants are admitted overnight after the device closure implantation. Then on subsequent out patient cardiology research clinic follow appointments on days (3-4) and (7-8).

NCT ID: NCT02914652 Completed - Clinical trials for Ventricular Septal Defect

The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects.

Start date: October 15, 2016
Phase: Phase 4
Study type: Interventional

The overall objective for this study is to test whether β2-agonists will affect the cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and healthy age- and gender-matched controls.

NCT ID: NCT02867930 Completed - Heart Valve Disease Clinical Trials

Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography

KDTEE
Start date: June 2016
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable alternative for moderate sedation in out-patient diagnostic trans-esophageal echocardiography.

NCT ID: NCT02861963 Completed - Clinical trials for Pulmonary Atresia With Ventricular Septal Defect

Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients

Start date: May 5, 2016
Phase: N/A
Study type: Interventional

The aim is to compare effective growth true hypoplastic pulmonary arteries using Right Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)

NCT ID: NCT02794584 Completed - Clinical trials for Pediatric Ventricular Septal Defects

Hybrid Closure of Congenital Heart Disease

Start date: January 2011
Phase: N/A
Study type: Interventional

Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric VSD in the clinical practice, precision assessment of perioperative its effectiveness and safety has already become an important issue that must be solved. On the basis of echocardiography, integrating with characteristics associated critical care, the investigators focus on precision assessment of perioperative effectiveness and safety of transthoracic hybrid closure for pediatric VSD, compared with conventional surgical sternotomy repair with cardiopulmonary bypass (CPB).

NCT ID: NCT02766569 Enrolling by invitation - Clinical trials for Atrial Septal Defect

International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients

IRFACODE-II
Start date: July 2016
Phase: N/A
Study type: Observational [Patient Registry]

The IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II device in patients with closure of secundum atrial septal defects (ASD II).