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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esophageal Probe | Experimental | 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 | Experimental | Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring. Intervention: Power limitation of RF generator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of oesophageal probe for temperature measurement | Device | The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Leipzig | Leipzig | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32820324 | Derived | Schoene K, Arya A, Grashoff F, Knopp H, Weber A, Lerche M, Konig S, Hilbert S, Kircher S, Bertagnolli L, Dinov B, Hindricks G, Halm U, Zachaus M, Sommer P. Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial. Europace. 2020 Oct 1;22(10):1487-1494. doi: 10.1093/europace/euaa209. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Power limitation of RF generator | Device | no probe utilized; Limit the RF Generator Output to 25W |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |