Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03246594

Acronym

OPERA

Enrollment

200

Registered

2017-08-11

Start date

2017-07-03

Completion date

2019-10-24

Last updated

2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, esophageal probe, thermolesion

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)

Interventions

DEVICEPlacement of oesophageal probe for temperature measurement

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

DEVICEPower limitation of RF generator

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026