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the efficacy and safety of atrial septal cryogenic ablation for PFO closure in patients with atrial fibrillation and PFO: a prospective randomized controlled study

the efficacy and safety of atrial septal cryogenic ablation for PFO closure in patients with atrial fibrillation and PFO: a prospective randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063957
Enrollment
Unknown
Registered
2022-09-21
Start date
2022-09-21
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

patent foramen ovale(PFO)

Interventions

Experimental group:Balloon cryoablation for atrial septal
Control group:Atrial septal balloon attached

Sponsors

Department of Cardiology, the First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years. 2. Patients with paroxysmal and short-term persistent atrial fibrillation (with history of atrial fibrillation =grade 2 on agitated saline contrast echocardiography. 4. Volunteered to participate in the clinical trial, and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The presence of thrombosis in left atrium or left atrial appendage confirmed by transesophageal echocardiography. 2. Combined with atrial septal aneurysm and atrial septal defect. 3. Combined with atrioventricular block. 4. Patients with severe pulmonary hypertension. 5. The anatomical characteristics of pulmonary veins are not suitable for balloon cryoablation. 6. Patients who could not complete the follow-up.

Design outcomes

Primary

MeasureTime frame
Successful rate of PFO closure;

Secondary

MeasureTime frame
Successful rate of operation;Complication rate;Recurrence rate;

Countries

China

Contacts

Public ContactJia Fengpeng

Department of Cardiology, the First Affiliated Hospital of Chongqing Medical University

jiafengpeng72@126.com+86 18580034871

Outcome results

None listed

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