Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation (OPERA)

Heart Center Leipzig - University Hospital

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Placement of oesophageal probe for temperature measurement; Device: Power limitation of RF generator

Study type: Interventional

Funder types: Other

Identifiers

NCT03246594

Opera-2016

Details and patient eligibility

About

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

Full 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)

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Esophageal Probe

Experimental group

Description:

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

Treatment:

Device: Placement of oesophageal probe for temperature measurement

No Esophageal Probe

Experimental group

Description:

Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring. Intervention: Power limitation of RF generator

Treatment:

Device: Power limitation of RF generator