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Study of Novel X-ray Technology for Measuring Cardiac Pressure in Patients with Atrial Fibrillation and Heart Failure

Clinical Value of Dynamic Digital Radiography in Assessment of Left Atrial Pressure in Patients with Atrial Fibrillation and Heart Failure with Preserved Ejection Fraction

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097061
Enrollment
Unknown
Registered
2025-02-12
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Atrial fibrillation combined with heart failure with preserved ejection fraction

Interventions

Gold Standard:Left atrial pressure directly measured through transseptal puncture during atrial fibrillation radiofrequency ablation procedure. This is currently the most accurate clinical method for
Index test:Mean pixel value of left atrial region measured by functional dynamic digital radiography

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Non-valvular AF patients aged 18-80 years; 2.Meeting HFpEF diagnostic criteria: a. H2FPEF score >= 6 points, and b. Left ventricular ejection fraction >= 50%; 3.Left atrial enlargement: a. Left atrial volume index > 34 mL/m², or b. Left atrial anteroposterior diameter > 39 mm (male) / > 38 mm (female); 4.Planned for radiofrequency ablation; 5.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Intracardiac thrombus detected by transesophageal echocardiography; 2.Hyperthyroidism; 3.Tumors or other diseases requiring treatment with life expectancy less than 1 year; 4.Conditions affecting left atrial imaging assessment, such as significant pleural effusion, active pulmonary infection, mediastinal mass, severe chest wall deformity, etc; 5.Pregnancy; 6.Other conditions that may affect the evaluation of study results.

Design outcomes

Primary

MeasureTime frame
Left atrial mean pixel value;

Secondary

MeasureTime frame
Left ventricular mean pixel value;

Countries

China

Contacts

Public ContactXinglin Yang

Peking Union Medical College Hospital

yangxinglindz@163.com+86 10 69151188

Outcome results

None listed

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