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NCT Number: NCT06842160

Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

1.Patients who are allergic to electronic devices or unable to wear watches

Treatment and study plan

Intervention Group

Device

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

Primary outcomes

  1. Incidence of Stroke

    Time frame: March 30, 2025 to March 30, 2035

    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).

  2. Incidence of Heart Failure

    Time frame: March 30, 2025 to March 30, 2035

    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).

  3. All-Cause Mortality Rate

    Time frame: March 30, 2025 to March 30, 2035

    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).

  4. Cardiovascular Mortality Rate

    Time frame: March 30, 2025 to March 30, 2035

    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).

  5. Rate of Rehospitalization

    Time frame: March 30, 2025 to March 30, 2035

    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).

  6. Incidence of Bleeding Events

    Time frame: March 30, 2025 to March 30, 2035

    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).

  7. Postoperative Atrial Fibrillation Burden

    Time frame: March 30, 2025 to March 30, 2035

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Song Zuo, M.D

CONTACT

[email protected]

1880142775

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Acronym: Polaris-AFCA

Important dates

Study start
2025
Primary completion
2035
Study completion
2036
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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