Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
NCT ID: NCT03246594
Last Updated: 2020-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-07-03
2019-10-24
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Esophageal Probe
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
Placement of oesophageal probe for temperature measurement
The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus
No Esophageal Probe
Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring.
Intervention: Power limitation of RF generator
Power limitation of RF generator
no probe utilized; Limit the RF Generator Output to 25W
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Indication for RF ablation of atrial fibrillation according to the recent guidelines
* Signed informed consent
* Age 18-85 years
Exclusion Criteria
* Intracardiac thrombus
* Contraindication for oral anticoagulation
* Conditions, that may complicate the positioning of the oesophageal probe
18 Years
85 Years
ALL
No
Sponsors
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Heart Center Leipzig - University Hospital
OTHER
Responsible Party
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Locations
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Heart Center Leipzig
Leipzig, , Germany
Countries
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References
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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.
Other Identifiers
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Opera-2016
Identifier Type: -
Identifier Source: org_study_id
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