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Ablation of Paroxysmal ATrial FibrillaTion GuidEd by Ablation Index: A Multi-center, Prospective Randomized Trial

Ablation of Paroxysmal ATrial FibrillaTion GuidEd by Ablation Index: A Multi-center, ProSpective Randomized Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022041
Enrollment
Unknown
Registered
2019-03-21
Start date
2019-03-19
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Atrial Fibrillation

Interventions

1:AI-guided PVI
2:CF-guided PVI

Sponsors

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-75 years; 2) Symptomatic paroxysmal AF; 3) At least one ECG documented AF within 6 months of the ablation procedure; 4) Patient is able and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) >4 cardioversions in prior 12 months; 2) MI, CABG or PCI within preceding 3 months; 3) Left atrial diameter >50mm; 4) Left ventricular ejection fraction by echocardiography <40%; 5) Heart failure with NYHA class III or IV; 6) History of heart surgery or any previous ablation for AF; 7) Intracardiac thrombus; 8) Contradictions to anticoagulation; 9) Females who are pregnant or breast feeding.

Design outcomes

Primary

MeasureTime frame
Freedom from AF/AFL/ATa recurrences at 12 months following ablation, without antiarrhythmic drug (type I/III) therapy;

Secondary

MeasureTime frame
Freedom from AF/AFL/ATa recurrences at 12 months following ablation, with or without antiarrhythmic drug (type I/III) therapy;Proportion of patients with AF/AFL/ATa occurring during the first 90 days post ablation;;Repeat ablation procedure due to recurrence of AF/AFL/ATa;AI-related parameters and the ratio of first-pass isolation;Total procedure duration, X-ray exposure time, PV isolation time;Incidence of peri-procedural complications;Quality of life measurements (SF-36);

Countries

China

Contacts

Public ContactChenyang Jiang

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

jiangchenyangmail@163.com+86 13857190051

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026