Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— OPERA  

Official title:

Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246594
• Other study ID #: Opera-2016
• Status: Completed
• Phase: N/A
• Start date: July 3, 2017
• Est. completion date: October 24, 2019

Study information

• Verified date: May 2020
• Source: Heart Center Leipzig - University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 24, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Germany	Heart Center Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oesophageal complications after RF Ablation depending on using an oesophageal probe	Incidence of oesophageal mucosa alterations in gastroscopy	Up to 6 months
Secondary	Rhythm stability after RF ablation of atrial fibrillation (AF)	Percentage of AF/AT recurrences in 7 day holter at 6 months	6 Months