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Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation (OPERA)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Placement of oesophageal probe for temperature measurement
Power limitation of RF generator
Sponsored by
Heart Center Leipzig - University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, esophageal probe, thermolesion

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Leipzig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Esophageal Probe

No Esophageal Probe

Arm Description

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

Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring. Intervention: Power limitation of RF generator

Outcomes

Primary Outcome Measures

Oesophageal complications after RF Ablation depending on using an oesophageal probe
Incidence of oesophageal mucosa alterations in gastroscopy

Secondary Outcome Measures

Rhythm stability after RF ablation of atrial fibrillation (AF)
Percentage of AF/AT recurrences in 7 day holter at 6 months

Full Information

First Posted
August 8, 2017
Last Updated
May 18, 2020
Sponsor
Heart Center Leipzig - University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03246594
Brief Title
Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
Acronym
OPERA
Official Title
Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
October 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart Center Leipzig - University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, esophageal probe, thermolesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esophageal Probe
Arm Type
Experimental
Arm Description
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
Arm Title
No Esophageal Probe
Arm Type
Experimental
Arm Description
Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring. Intervention: Power limitation of RF generator
Intervention Type
Device
Intervention Name(s)
Placement of oesophageal probe for temperature measurement
Intervention Description
The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus
Intervention Type
Device
Intervention Name(s)
Power limitation of RF generator
Intervention Description
no probe utilized; Limit the RF Generator Output to 25W
Primary Outcome Measure Information:
Title
Oesophageal complications after RF Ablation depending on using an oesophageal probe
Description
Incidence of oesophageal mucosa alterations in gastroscopy
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Rhythm stability after RF ablation of atrial fibrillation (AF)
Description
Percentage of AF/AT recurrences in 7 day holter at 6 months
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Heart Center Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32820324
Citation
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.
Results Reference
derived

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Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

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