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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Atrial Fibrillation (AF)

Being tested

intervention group

Keywords

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

Medical subject headings

Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• intervention groupDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

   Measured: March 30, 2025 to March 30, 2035

2. 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).

   Measured: March 30, 2025 to March 30, 2035

3. 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).

   Measured: March 30, 2025 to March 30, 2035

4. 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).

   Measured: March 30, 2025 to March 30, 2035

5. 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).

   Measured: March 30, 2025 to March 30, 2035

6. 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).

   Measured: March 30, 2025 to March 30, 2035

7. 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).

   Measured: March 30, 2025 to March 30, 2035

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Feb 2025
2. Study start30 Mar 2025 (estimated)
3. Primary completion30 Mar 2035 (estimated)
4. Study completion30 Mar 2036 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.