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A clinical trial to evaluate the safety and feasibility of using a esophageal retractor during Atrial Fibrillation Ablation

A clinical trial to evaluate the safety and feasibility of using a esophageal retractor during Atrial Fibrillation Ablation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040985
Enrollment
Unknown
Registered
2020-12-16
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

esophageal injury during Atrial Fibrillation Ablation

Interventions

Experimental group:esophageal retractor

Sponsors

Beijing An-Zhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Subject is willing and able to provide informed consent; 2.Subject is between ages 18 – 80 years; 3.Subject has an atrial or ventricular arrhythmia requiring radiofrequency ablation on the posterior aspect of the heart; 4.Subject is capable of adhering to the expectations of the study protocol (e.g., attending follow-up visit).

Exclusion criteria

Exclusion criteria: 1.Patients with a history of severe cardiovascular and pulmonary diseases, including severe cardiac rhythm or abnormal conduction, Acute coronary syndrome, congestive heart failure; 2.Peoplehave pathological change in nasal cavity and throat; 3.There were contraindications to endoscopy; 4.Chest radiation or Nasal Cavity Surgery; 5.Severe spinal deform; 6.Atrial Fibrillation Catheter Ablation Surgical contraindication; 7.Significant abnormality on Swallowing Impairment Score; 8.Anticoagulant contraindications; 9.Drug allergy; 10.Patients with active infection; 11.Subject is pregnant or plans to become pregnant; 12.Mental impairment; 13.Subject with known alcohol or drug dependence; 14.Patients who have received other clinical research drugs or treatments within 3 months; 15.The researchers considered that the subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons.

Design outcomes

Primary

MeasureTime frame
the distance from the trailing esophageal edge to the closest point of the ablation line;

Countries

China

Contacts

Public ContactChangsheng Ma
13671346119@163.com+86 10-64456412

Outcome results

None listed

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