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The efficacy and safety of IntraCardiac Echocardiography (ICE)-guided minimized fluoroscopy ablation in patients with Paroxysmal Atrial Fibrillation (PAF): A Non-inferior, Multi-center, Prospective Randomized Trial (PAF-ICE trial)

The efficacy and safety of IntraCardiac Echocardiography (ICE)-guided minimized fluoroscopy ablation in patients with Paroxysmal Atrial Fibrillation (PAF): A Non-inferior, Multi-center, Prospective Randomized Trial (PAF-ICE trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033624
Enrollment
Unknown
Registered
2020-06-07
Start date
2020-06-08
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

Atrial fibrillation

Interventions

ICE-guided Minimized fluoroscopy group: ICE-guided AF ablation
Tradional group without ICE:Tradional AF ablation without ICE

Sponsors

Sir Run Run Shaw Hospital, School 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 electrocardiographically documented AF within 6 months of the ablation procedure; 4. First catheter ablation; 5. Patient is able and willing to provide written informed consent and complete the follow-up.

Exclusion criteria

Exclusion criteria: 1. Myocardial infarction, CABG or PCI within preceding 3 months; 2. Left atrial diameter >50mm; 3. Left ventricular ejection fraction by echocardiography <40%; 4. NYHA class III or IV or decompensated heart failure; 5. History of cardiac surgery or any previous ablation for AF; 6. Intracardiac thrombus or tumor; 7. Severe valvular heart disease; 8. Secondary atrial fibrillation, i.e. hyperthyroidism, hypokalemia, etc.; 9. Contradictions to anticoagulation; 10. Females who are pregnant or breast feeding.

Design outcomes

Primary

MeasureTime frame
the first documented clinical recurrence occurring more than 90 days after the index ablation procedure.;

Secondary

MeasureTime frame
Time of radioprotective apron usage in procedure-related staff;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;Total procedure duration;X-ray exposure time;PV isolation time;Incidence of peri-procedural complications;Quality of Life;

Countries

China

Contacts

Public ContactChenyang Jiang

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

cyjiang@zju.edu.cn+86 13857190051

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026