AWARE Registry: Wearable ECG in Structural Heart Interventions

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06236776
Study type	Observational
Source	Yonsei University
Contact	Iksung Cho
Phone	82-2-2228-8442
Email	iksungcho@yuhs.ac
Status	Not yet recruiting
Phase
Start date	February 2024
Completion date	June 2028

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06192173` - Patent Foramen Ovale Closure in Migraine
Recruiting	`NCT04610463` - Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism	N/A
Completed	`NCT02882815` - Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder	N/A
Completed	`NCT04604015` - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt	N/A
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Not yet recruiting	`NCT04549272` - Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Terminated	`NCT01018355` - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI	N/A
Completed	`NCT00831259` - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)	N/A
Not yet recruiting	`NCT05360771` - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System	N/A
Recruiting	`NCT05546320` - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale	Phase 4
Recruiting	`NCT05561660` - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)	Phase 4
Completed	`NCT03904277` - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting	`NCT06120270` - CeraFlex PFO Closure System PMCF Study
Terminated	`NCT01773252` - Right to Left Cardiac Shunt Detection	Phase 3
Completed	`NCT01216423` - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale	N/A
Completed	`NCT03377465` - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis	N/A
Active, not recruiting	`NCT04738071` - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting	`NCT06413147` - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting	`NCT06344494` - Cardiac Interventional ICE Imaging Trial	N/A