NCT03246594

Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Heart Center Leipzig - University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation of atrial fibrillation regarding oesophageal ulcers after ablation.

Detailed description

The Trial will evaluate the influence of oesophageal probes in RF-ablation of atrial fibrillation regarding oesophageal complications after ablation. 200 patients will be prospectively randomised into 2 groups. The conventional group will undergo RF-Ablation of atrial fibrillation using an oesophageal probe to measure the temperature during ablation. In the other group will receive ablation using fixed energy levels (25 Watt) at the posterior left atrial (LA) Wall without an oesophageal probe , All patients will get a gastroscopy for evaluation of oesophageal complications the day after the procedure. All patients will have a 6 months follow up (FU) in our clinic to be reevaluated for complications (primary endpoint) and rhythm stability. (secondary endpoint)

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Placement of oesophageal probe for temperature measurement	The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus
DEVICE	Power limitation of RF generator	no probe utilized; Limit the RF Generator Output to 25W

Timeline

• Start date: 2017-07-03
• Primary completion: 2019-04-25
• Completion: 2019-10-24
• First posted: 2017-08-11
• Last updated: 2020-05-20

Locations

1 site across 1 country: Germany