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Completed

NCT Number: NCT03246594

Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center Leipzig

Leipzig, 04289, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement of oesophageal probe for temperature measurement

Device

The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus

Power limitation of RF generator

Device

no probe utilized; Limit the RF Generator Output to 25W

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Registry information

Acronym: OPERA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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