NCT06842160

Brief Summary

The purpose of this study is to evaluate the effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
119mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2025Mar 2036

First Submitted

Initial submission to the registry

December 4, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2025

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2035

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2036

Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

10 years

First QC Date

December 4, 2024

Last Update Submit

February 19, 2025

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation Burden、 Catheter AblationPhotoplethysmographyWearable devices.

Outcome Measures

Primary Outcomes (7)

  • Incidence of Stroke

    The rate of stroke occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of strokes per participant).

    March 30, 2025 to March 30, 2035

  • Incidence of Heart Failure

    The rate of heart failure occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of heart failure episodes per participant).

    March 30, 2025 to March 30, 2035

  • All-Cause Mortality Rate

    The rate of all-cause mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of deaths per participant).

    March 30, 2025 to March 30, 2035

  • Cardiovascular Mortality Rate

    The rate of cardiovascular-related mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of cardiovascular-related deaths per participant).

    March 30, 2025 to March 30, 2035

  • Rate of Rehospitalization

    The rate of rehospitalization due to any medical cause in the study population. The unit of measure will be the frequency of events (e.g., number of rehospitalization events per participant).

    March 30, 2025 to March 30, 2035

  • Incidence of Bleeding Events

    The rate of bleeding events (such as major or minor bleeding) in the study population. The unit of measure will be the frequency of events (e.g., number of bleeding events per participant).

    March 30, 2025 to March 30, 2035

  • Postoperative Atrial Fibrillation Burden

    The frequency and severity of atrial fibrillation episodes observed in participants after a surgical procedure, measured using data collected by an intelligent heart rate monitoring watch utilizing a PPG algorithm. The unit of measure will be frequency of events (e.g., number of episodes per participant).

    March 30, 2025 to March 30, 2035

Interventions

intervention groupDEVICE

A smart electrocardiogram watch based on the PPG algorithm for monitoring atrial fibrillation load after catheter ablation.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone catheter ablation for atrial fibrillation and meet age and health standards are able to use electrocardiographic watches for long-term monitoring

You may qualify if:

  • Atrial fibrillation patients diagnosed by electrocardiogram
  • Received catheter ablation procedure
  • Willing to use long-range electrocardiogram monitoring equipment

You may not qualify if:

  • Patients who are allergic to electronic devices or unable to wear watches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Electrocardiogram data、Photoplethysmography data

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Song Zuo, M.D

CONTACT

1880142775song_zuo@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

February 24, 2025

Study Start

March 30, 2025

Primary Completion (Estimated)

March 30, 2035

Study Completion (Estimated)

March 30, 2036

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)