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N/A Completed N=80 Randomized Treatment

RF Power, LSI and Oesophageal Temperature Alerts During AF Ablation (PiLOT-AF Study)

Source: ClinicalTrials.gov NCT02619396 ↗
Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Jul 2020
Primary outcomePrimary: Rate of Oesophageal Temperature Alerts During Radiofrequency Energy (RF) Ablation on the Left Atrial (LA) Posterior Wall — 18; 18; 19; 19 Participants

Summary

Atrial fibrillation (AF) is a very common abnormal heart rhythm, triggered by rapid electrical activity originating from the pulmonary veins (PVs) that drain blood from the lungs back to the left atrium (LA). Ablation of the junction between the PVs and the LA, electrically isolating the veins from the heart, is the key to prevent AF. When using radiofrequency energy (RF), transmural lesions are required to achieve permanent pulmonary vein isolation (PVI). New technologies are currently available to predict the ablation lesion depth and to guide the duration of each application. However, deeper lesions mean a higher risk of overheating and damage of adjacent structures such as the esophagus that lies against the back wall of the LA. In order to minimize this risk, the investigators continuously monitor the temperature inside the esophagus during the procedure through a probe placed in the esophagus and they promptly terminate energy delivery in case of any esophageal temperature rises more than 39°C. To date, it is not known if a low power for a longer time is better than a high power for a shorter time when ablating on the LA posterior wall in order to create permanent scars without heating the esophagus. Therefore, the investigators plan to compare the incidence of esophageal temperature alerts and the success of the procedure with four different energy settings during ablation on the LA posterior wall.

Outcome Measures

OutcomeResultp-value
PRIMARY
Rate of Oesophageal Temperature Alerts During Radiofrequency Energy (RF) Ablation on the Left Atrial (LA) Posterior Wall
18; 18; 19; 19
PRIMARY
Oesophageal Temperature Alerts Per Patient
4; 4; 7; 4
SECONDARY
Rate of First-pass Pulmonary Vein Isolation (PVI)
59; 59; 38; 59
SECONDARY
Rate of Acute Pulmonary Vein Reconnection (PVR)
5; 10; 17; 5
SECONDARY
Total Procedure Time
180; 165; 180; 165
SECONDARY
Total Radiofrequency Energy (RF) Time for Pulmonary Vein Isolation (PVI)
28.4; 23.8; 38; 22
SECONDARY
Freedom From Atrial Fibrillation
8; 3; 7; 2
SECONDARY
Esophageal Symptoms After the Atrial Fibrillation (AF) Ablation
0; 0; 0; 0

Eligibility Criteria

Inclusion Criteria

  • male or female, aged 18 to 80 years;
  • willing and able to give informed consent for participation in the study;
  • history of symptomatic and drug-refractory atrial fibrillation;
  • planned atrial fibrillation (AF) ablation on a clinical basis.

Exclusion Criteria

  • previous AF ablation;
  • pregnancy, trying for a baby or breast feeding;
  • oesophageal obstruction (mass, stricture), diverticulum or varices, tracheo-oesophageal fistula or any other oesophageal conditions prohibiting the use of oesophageal temperature probe for continuous luminal temperature monitoring;
  • any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02619396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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