A multi-center clinical study for implantation of long-range ECG devices to monitor atrial fibrillation load after frozen balloon ablation in patients with atrial fibrillation

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026364

Enrollment

Unknown

Registered

2019-10-03

Start date

2020-01-01

Completion date

Unknown

Last updated

2019-10-14

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

Conditions

Atrial fibrillation

Interventions

Implant group:implanting a long-term ECG monitoring device +Holter monitoring

control group:Holter monitoring

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) clinical diagnosis of atrial fibrillation was confirmed. Electrocardiogram records showed that atrial fibrillation lasted for more than 30 s and met the indications of radiofrequency ablation; 2) freezing balloon ablation of atrial fibrillation was performed for the first time; 3) aged >= 18 years, regardless of gender; 4) patients voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) patients with severe heart disease, including the New York heart function classification standard for levels III or IV, patients are not able to lay down, and severe arrhythmia; 2) life expectancy < 1 year; 3) previous atrial fibrillation ablation; 4) abnormal coagulation or allergy to anticoagulant drugs; 5) patients with malignant tumor; 6) pregnant women.

Design outcomes

Primary

Measure	Time frame
Recurrence rate of AF;	—

Countries

China

Contacts

Public ContactLi Guangping

Department of Cardiology, the Second Hospital of Tianjin Medical University

tjcardiol@126.com+86 022-88328628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026