Skip to content

A Controlled Study on Pulmonary Vein Isolation for Atrial Fibrillation under Half-Concentration Normal Saline Perfusion

Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation with Half-Normal Saline Irrigation for Pulmonary Vein Isolation: A Prospective,Single-center Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124413
Enrollment
Unknown
Registered
2026-05-12
Start date
2025-10-06
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Paroxysmal atrial fibrillation

Interventions

A:Atrial fibrillation catheter ablation, pulmonary vein isolation performed using a whole-process 90W/4s ablation mode under standard saline concentrati.
B:Anterior wall of the pulmonary vein ablation using half saline at 90w/4s, posterior wall pulmonary vein isolation using standard saline concentration.

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age =18 years, regardless of gender. 2.Diagnosed with paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation. 3.The subject or their legally authorized representative is able to understand the study purpose, voluntarily agrees to participate by providing written informed consent, and is willing to complete all required follow-ups as per the protocol.

Exclusion criteria

Exclusion criteria: 1.Severe heart failure (New York Heart Association Class IV); 2.Myocardial infarction or unstable angina within 1 month prior to enrollment. 3.Active bleeding or uncorrected coagulation disorders (defined as: platelet count 2 times the upper limit of normal). 4.Leukopenia (WBC 3 times the upper limit of normal). 6.Renal insufficiency (serum creatinine =3.5 mg/dL) or requiring dialysis. 7.Presence of intracardiac thrombus, tumor, or vegetation. 8.Severe structural heart disease deemed by the investigator to potentially interfere with the procedure (e.g., severe mitral, tricuspid, or aortic valve deformity; Tetralogy of Fallot; transposition of the great arteries, etc.). 9.Absence of inferior vena cava, or presence of thrombus/severe stenotic-occlusive disease in the interventional access route. 10.Hemodynamic instability or critically ill condition requiring emergency surgery. 11.Presence or suspicion of infective endocarditis or systemic active infection. 12.Participation in another clinical trial within 3 months prior to enrollment or current participation in another drug/device clinical trial without having reached its primary endpoint. 13.Pregnancy, lactation, plan for pregnancy within 1 year, or unwillingness to use effective contraception. 14.Any other condition considered by the investigator to make the subject unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
the first pass isolation rate of pulmonary veins;

Secondary

MeasureTime frame
the rate of steam pops;

Countries

China

Contacts

Public ContactYu Yibo

The First Affiliated Hospital of Ningbo University

mubird@foxmail.com+86 5748687085

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026