Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation (OPERA)
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|ClinicalTrials.gov Identifier: NCT03246594|
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Placement of oesophageal probe for temperature measurement Device: Power limitation of RF generator||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation|
|Actual Study Start Date :||July 3, 2017|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: 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
Device: Placement of oesophageal probe for temperature measurement
The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus
Experimental: 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
Device: Power limitation of RF generator
no probe utilized; Limit the RF Generator Output to 25W
- Oesophageal complications after RF Ablation depending on using an oesophageal probe [ Time Frame: Up to 6 months ]Incidence of oesophageal mucosa alterations in gastroscopy
- Rhythm stability after RF ablation of atrial fibrillation (AF) [ Time Frame: 6 Months ]Percentage of AF/AT recurrences in 7 day holter at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246594
|Contact: Philipp Sommer, MD||034186525 ext email@example.com|
|Heart Center Leipzig||Recruiting|
|Leipzig, Germany, 04289|
|Contact: Philipp Sommer +49865 ext 252020 firstname.lastname@example.org|