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

May 18, 2020 updated by: Heart Center Leipzig - University Hospital
The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation of atrial fibrillation regarding oesophageal ulcers after ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • Heart Center Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oesophageal complications after RF Ablation depending on using an oesophageal probe
Time Frame: Up to 6 months
Incidence of oesophageal mucosa alterations in gastroscopy
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2017

Primary Completion (Actual)

April 25, 2019

Study Completion (Actual)

October 24, 2019

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Opera-2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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