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The Transmural Efficacy of Pulmonary Vein Isolation Guided by the Combination of Ablation Index and Unipolar Electrogram Modification in Patients with Paroxysmal Atrial Fibrillation: Protocol of Pilot Study

The Transmural Efficacy of Pulmonary Vein Isolation Guided by the Combination of Ablation Index and Unipolar Electrogram Modification in Patients with Paroxysmal Atrial Fibrillation: Protocol of Pilot Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063758
Enrollment
Unknown
Registered
2022-09-16
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

atrial fibrillation

Interventions

Group 1 :

Sponsors

Ningbo First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The age of the patient should be between 18 and 75 years old; 2. The patient is diagnosed with paroxysmal atrial fibrillation by 12-lead electrocardiogram or dynamic electrocardiogram, that is, the duration of atrial fibrillation does not exceed 7 days and can be terminated by itself or intervention, and should meet the indications for radiofrequency ablation; 3. The patient understands and can sign the written informed consent of the study; 4. Patients can comply with the research requirements for follow-up.

Exclusion criteria

Exclusion criteria: 1. The duration of symptomatic AF reaches or exceeds 7 days; 2. Previously received AF ablation therapy (including radiofrequency ablation and/or cryoballoon ablation); 3. Platelet count is lower than 80×10^9/L or systemic anticoagulation is contraindicated (heparin, oral warfarin or new oral anticoagulants [noveloralanticoagulants, NOACs]); 4. Left atrial anteroposterior diameter >= 55 mm (transthoracic echocardiography, TTE, parasternal long-axis view); 5. Left atrium or left atrial appendage thrombus (transesophagealechocardiography, TEE, or multi-slice CT); 6. Combined with severe structural heart disease (moderate or severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, or other severe valvular heart disease); 7. Abnormal thyroid function that cannot be controlled by combined drugs; 8. Combined with abnormal liver function (AST or ALT > 3 times the upper limit of normal) or abnormal renal function (SCr > 3.5 mg/dl or CCr < 30 ml/min); 9. Have a history of surgery within the past 3 months; 10. Recent history of fever, infection or aldosterone medication; 11. There are contraindications for radiofrequency ablation (such as pregnancy status, allergy to contrast medium, acute or chronic heart failure, acute myocardial infarction, severe respiratory function or brain insufficiency, etc.); 12. Those whose life expectancy is less than 12 months due to chronic lung disease or malignant tumor.

Design outcomes

Primary

MeasureTime frame
monopolar electrogram morphology;

Countries

China

Contacts

Public ContactChu Huimin

Ningbo First Hospital

epnbheart@126.com+86 13566336742

Outcome results

None listed

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