Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

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

Detailed Description
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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)

Official Title
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Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Placement of oesophageal probe for temperature measurement
* Device: Power limitation of RF generator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esophageal Probe<br>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 | Device: Placement of oesophageal probe for temperature measurement<br>* The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus<br>|
| Experimental: No Esophageal Probe<br>Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring. Intervention: Power limitation of RF generator | Device: Power limitation of RF generator<br>* no probe utilized; Limit the RF Generator Output to 25W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oesophageal complications after RF Ablation depending on using an oesophageal probe | Incidence of oesophageal mucosa alterations in gastroscopy | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhythm stability after RF ablation of atrial fibrillation (AF) | Percentage of AF/AT recurrences in 7 day holter at 6 months | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, esophageal probe, thermolesion