Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
OPERA
1 other identifier
interventional
200
1 country
1
Brief Summary
The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation of atrial fibrillation regarding oesophageal ulcers after ablation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2017
CompletedFirst Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2019
CompletedMay 20, 2020
May 1, 2020
1.8 years
August 8, 2017
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oesophageal complications after RF Ablation depending on using an oesophageal probe
Incidence of oesophageal mucosa alterations in gastroscopy
Up to 6 months
Secondary Outcomes (1)
Rhythm stability after RF ablation of atrial fibrillation (AF)
6 Months
Study Arms (2)
Esophageal Probe
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring. Intervention: Power limitation of RF generator
Interventions
The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus
no probe utilized; Limit the RF Generator Output to 25W
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Center Leipzig
Leipzig, 04289, Germany
Related Publications (1)
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.
PMID: 32820324DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 11, 2017
Study Start
July 3, 2017
Primary Completion
April 25, 2019
Study Completion
October 24, 2019
Last Updated
May 20, 2020
Record last verified: 2020-05