AWARE Registry: Wearable ECG in Structural Heart Interventions

January 24, 2024 updated by: Yonsei University

Arrhythmia Assessment in Structural Cardiac Interventions Using Wearable ECG Monitoring: AWARE Registry

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale

Description

Inclusion Criteria:

  • Adult ≥ 19 year-old
  • Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
  • Patients provided with the written, informed consent to participate in this study

Exclusion Criteria:

  • Patients who had paroxysmal, persistent, or chronic AF
  • Life expectancy < 12 months
  • Subject who the investigator deems inappropriate to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of atrial fibrillation
Time Frame: Immediate post-operative
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
Immediate post-operative
Occurrence of atrial fibrillation
Time Frame: 18 month
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
18 month
Occurrence of atrial fibrillation
Time Frame: 30 month
Occurrence of atrial fibrillation at Immediate post-operative, 18, and 30 month on wearable ECG monitoring
30 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause-death
Time Frame: Immediate post-operative, 18 month , 30 month
Immediate post-operative, 18 month , 30 month
hospitalization for heart failure
Time Frame: Immediate post-operative, 18 month , 30 month
hospitalization for heart failure: data from electronic medical record in Yonsei university health system
Immediate post-operative, 18 month , 30 month
new atrial fibrillation
Time Frame: Immediate post-operative, 18 month , 30 month
Immediate post-operative, 18 month , 30 month
new atrial tachycardia
Time Frame: Immediate post-operative, 18 month , 30 month
Immediate post-operative, 18 month , 30 month
high burden of APC/PVC (>15%)
Time Frame: Immediate post-operative, 18 month , 30 month
high burden of APC/PVC ( >15%): on wearable ECG monitoring
Immediate post-operative, 18 month , 30 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Iksung Cho, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2023-0031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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