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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Heartcenter Leipzig GmbH

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Philipp Sommer, M.D., FHRS, FESC, Heartcenter Leipzig GmbH
ClinicalTrials.gov Identifier:	NCT03246594 History of Changes
Other Study ID Numbers:	Opera-2016
First Posted:	August 11, 2017
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, Heartcenter Leipzig GmbH:

atrial fibrillation; esophageal probe; thermolesion

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes