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Atrial Septal Defect clinical trials

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NCT ID: NCT06431178 Recruiting - General Anesthesia Clinical Trials

General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous closure of atrial septal defect on hemodynamic changes.

NCT ID: NCT06344494 Not yet recruiting - Atrial Fibrillation Clinical Trials

Cardiac Interventional ICE Imaging Trial

INTELICE
Start date: May 2024
Phase: N/A
Study type: Interventional

The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process.

NCT ID: NCT06298344 Recruiting - Clinical trials for Congenital Heart Disease

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

Start date: May 1, 2024
Phase: Early Phase 1
Study type: Interventional

Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions.

NCT ID: NCT06236776 Not yet recruiting - Clinical trials for Patent Foramen Ovale

AWARE Registry: Wearable ECG in Structural Heart Interventions

Start date: February 2024
Phase:
Study type: Observational

This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale. Transthoracic echocardiography will be performed before the procedure, immediately after, and at 6, 18, 30 months after the procedure. Wearable ECG monitoring (> 3 days) will be performed before the procedure or immediately after procedure. Demographic, laboratory, hemodynamic data during procedure, and non-invasive imaging dat are obtained.

NCT ID: NCT06139679 Completed - Clinical trials for Atrial Septal Defect

Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study

Start date: March 1, 2022
Phase:
Study type: Observational

Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses a clinical challenge on whether or not to close the defect. Closing the defect increases the risk of low cardiac output syndrome (LCOS), while leaving the defect open may eventually lead to irreparable shunt reversal, hypoxemia, and death. The implementation of a fenestrated patch may halt LCOS while adding volume to the left heart. Methods: this is an analytical observational study involving patients with ostium secundum defect with PH who were operated on in Dr. Soetomo Hospital between January 2017 and October 2021. The aim of this study is to evaluate the improvement in left ventricular size during both systole and diastole.

NCT ID: NCT05931835 Not yet recruiting - Atrial Fibrillation Clinical Trials

Feasibility Study on the VERAFEYE System

LUMINIzE
Start date: August 15, 2024
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure. Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.

NCT ID: NCT05887700 Not yet recruiting - Clinical trials for Atrial Septal Defect

Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up

Start date: May 2024
Phase:
Study type: Observational

The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.

NCT ID: NCT05688670 Recruiting - Pain, Procedural Clinical Trials

Regional Anesthesia Following Pediatric Cardiac Surgery

Start date: March 29, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.

NCT ID: NCT05540769 Recruiting - Clinical trials for Atrial Septal Defect

Holter and ECG Changes After Transcatheter Closure Of ASD In Children

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Atrial septal defects (ASD) account for 10% of all congenital heart defects [1]. Hemodynamic consequences of an ASD are dilatation of the right atrium and right ventricle (RV) because of the volume overload due to the left-to-right shunt through the ASD.For several decades, surgical closure has been considered the standard method of repairing a secundum ASD [2]. Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars [3]. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure [4]. During the last decade , ASD device closure , has finally replaced surgical ASD repair in most patients as the standard method of repair for the secundum ASD[5,6]. Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) [7]. Therefore, many authors suggest ASD closure before adulthood [8,9]. Classical ECG findings for a significant ASD are prolongation of the PR interval, prolongation of the QRS duration and right axis deviation of the QRS [10]. Percutaneous ASD closure is an ideal situation to study changes of RV dimensions and their impact on ECG as interferences from cardiopulmonary bypass, cardiac incisions and sutures on the right atrium and on the interatrial septum are excluded[11].

NCT ID: NCT05371366 Recruiting - Clinical trials for Atrial Septal Defect

The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)

Start date: April 22, 2022
Phase: N/A
Study type: Interventional

A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion. Compared with the traditional atrial septal occluder, this new atrial septal occluder supports re-puncture after occluder implantation. Thus those patients who have undergone atrial septal defect closure with the novel device may be eligible for future radiofrequency ablation of atrial fibrillation or mitral valve intervention. The trial is expected to enroll 128 patients who will be randomly assigned to the test group or control group in a 1:1 ratio. Patients in test group will received ReAces occluder,and the others the regular occluder.The experiment is scheduled to enroll 128 patients who will be randomly allocated to one of two groups: test or control. Patients in the test group will receive a ReAces occluder, while those in the control group will receive a standard occluder.The safety and efficacy of the two groups at 1 year after surgery will be compared.