NCT07512037Toborzás még nem indult
Burden-Evaluated Active Therapy for AF Using Continuous Wearables BEAT-AF Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 6.
Rövid összefoglaló (regiszter, angolul)
Traditional AF classification (e.g., paroxysmal, persistent, permanent) relies largely on patient-reported symptoms and intermittent electrocardiographic monitoring, which cannot continuously or objectively reflect disease progression, nor effectively inform optimal intervention timing. Although "AF burden" (i.e., duration of AF episodes) has emerged as a potential marker, its association with clinical outcomes remains inconsistent due to limitations in monitoring methods and its one-dimensional nature. Based on our previous work, investigators developed a five-dimensional AF progression model using photoplethysmography (PPG) signals collected from wearable devices. This model quantifies AF progression across five domains: episode frequency, duration, temporal aggregation, circadian rhythm, and tachycardia burden, enabling continuous and multidimensional assessment. Prior validation has demonstrated high agreement with 24-hour Holter monitoring and effective identification of high-risk patients. The BEAT-AF trial is designed to evaluate the clinical utility of this model in a real-world setting. Specifically, investigators will investigate whether early intervention (e.g., optimization of medical therapy or consideration of catheter ablation) in patients with elevated five-dimensional AF burden (≥4.59%) can reduce symptoms, rhythm/rate-related abnormalities, and AF-related adverse events (such as stroke and heart failure). This study is expected to provide new evidence for dynamic monitoring of AF progression, optimal timing of intervention, and personalized management strategies, ultimately improving patient outcomes.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 3194 (tervezett)
- Első benyújtás
- 2026. márc. 23.
- Kezdés
- 2026. ápr.
- Elsődleges befejezés
- 2028. jún.
- Fő szponzor
- Navy General Hospital, Beijing
- Betegségek
- Pitvarfibrilláció
- NCT-szám
- NCT07512037
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 3194
- 2026. ápr. és az elsődleges befejezés (2028. jún.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- Has an implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device.
- There may be skin diseases, limb deformities or allergies that prevent the proper wearing of wearable devices on the upper limbs.
- Having active mental disorders or cognitive impairments, as well as other conditions that result in lack of or restricted ability to act, and which, in the judgment of the researchers, make it impossible for the subject to comply with the trial protocol.
Egyéb
- During pregnancy, lactation, or planning to become pregnant during the trial period.
- At the same time, participate in other clinical trials that may interfere with the results of this study
Kiket keres a vizsgálat
- Inpatients ≥18 years of age at admission;
- Paroxysmal atrial fibrillation was diagnosed;
- Own a smart phone and a smart watch and be able to operate them basically;
- Before being enrolled, the average daily atrial fibrillation burden was calculated to be ≥ 4.59% based on monitoring through an intelligent wristwatch for at least 3 days;
- The treatment status meets any of the following conditions:
- If anticoagulation therapy is being administered, the treatment plan must be stable for at least 4 weeks;
- If heart rate or rhythm control medications are being used, the treatment plan must be stable for at least 4 weeks;
- Or no specific rhythm control treatment for atrial fibrillation is being received;
- Sign the informed consent form
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Sixth Medical Center of Chinese PLA General Hospital | Beijing | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.