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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06842160

Acronym

Polaris-AFCA

Enrollment

10000

Registered

2025-02-24

Start date

2025-03-30

Completion date

2036-03-30

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation Burden、 Catheter Ablation, Photoplethysmography, Wearable devices.

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.

Interventions

DEVICEintervention group

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Atrial fibrillation patients diagnosed by electrocardiogram 2. Received catheter ablation procedure 3. Willing to use long-range electrocardiogram monitoring equipment

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Stroke	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).
Incidence of Heart Failure	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).
All-Cause Mortality Rate	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).
Cardiovascular Mortality Rate	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).
Rate of Rehospitalization	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).
Incidence of Bleeding Events	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).
Postoperative Atrial Fibrillation Burden	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).

Countries

China

Contacts

Primary ContactSong Zuo, M.D

song_zuo@126.com1880142775

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026