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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
Sponsor:
Information provided by (Responsible Party):
Philipp Sommer, Heart Center Leipzig - University Hospital

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Placement of oesophageal probe for temperature measurement Device: Power limitation of RF generator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Oesophageal complications after RF Ablation depending on using an oesophageal probe [ Time Frame: Up to 6 months ]
    Incidence of oesophageal mucosa alterations in gastroscopy


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Philipp Sommer, MD 034186525 ext 2020 philipp.sommer@helios-kliniken.de

Locations
Germany
Heart Center Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Philipp Sommer    +49865 ext 252020    philipp.sommer@helios-kliniken.de   
Sponsors and Collaborators
Heart Center Leipzig - University Hospital
More Information
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Responsible Party: Philipp Sommer, M.D., FHRS, FESC, Heart Center Leipzig - University Hospital
ClinicalTrials.gov Identifier: NCT03246594     History of Changes
Other Study ID Numbers: Opera-2016
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philipp Sommer, Heart Center Leipzig - University Hospital:
atrial fibrillation
esophageal probe
thermolesion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes