Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Placement of oesophageal probe for temperature measurement; Device: Power limitation of RF generator

• Registration Number: NCT03246594
• Lead Sponsor: Heart Center Leipzig - University Hospital

Brief 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)

Study Timeline

• Study Start: 2017-07-03
• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-11
• Primary Completion: 2019-04-25
• Study Completion: 2019-10-24
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 12 lead ECG with documented atrial fibrillation
• Indication for RF ablation of atrial fibrillation according to the recent guidelines
• Signed informed consent
• Age 18-85 years

Exclusion Criteria

• Pregnancy or possible pregnancy without negative test within 48h prior to ablation
• Intracardiac thrombus
• Contraindication for oral anticoagulation
• Conditions, that may complicate the positioning of the oesophageal probe

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esophageal Probe	Placement of oesophageal probe for temperature measurement	Participants in this group will receive ablation for atrial fibrillation with a oesophageal probe placed for temperature monitoring. Placement of oesophageal probe for temperature measurement
No Esophageal Probe	Power limitation of RF generator	Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring. Intervention: Power limitation of RF generator

Primary Outcome Measures

Name	Time	Method
Oesophageal complications after RF Ablation depending on using an oesophageal probe	Up to 6 months	Incidence of oesophageal mucosa alterations in gastroscopy

Secondary Outcome Measures

Name	Time	Method
Rhythm stability after RF ablation of atrial fibrillation (AF)	6 Months	Percentage of AF/AT recurrences in 7 day holter at 6 months

Trial Locations

Locations (1)

Heart Center Leipzig; 🇩🇪 Leipzig, Germany