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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619396
Recruitment Status : Completed
First Posted : December 2, 2015
Results First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Procedure: Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Procedure: Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Procedure: Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Not Applicable

Detailed Description:

The PiLOT-AF study is a prospective single-centre randomized observational study aiming at comparing different radiofrequency energy (RF) settings during atrial fibrillation (AF) ablation on the left atrial (LA) posterior wall, in terms of esophageal heating, acute and long-term procedure success and procedural complications.

Patients scheduled for their first RF ablation, because of a history of symptomatic and drug-refractory paroxysmal or persistent AF, will be considered for inclusion in the study.

Potential subjects will initially be approached 4-6 weeks before their ablation procedure, in order to give them enough time to consider the information, to ask questions to the investigators, their family doctor or other independent parties to decide whether they wish to participate in the study or not.

For those interested in participation, a baseline assessment will be arranged to coincide with their standard pre-admission visit, for informed consent, screening and eligibility assessment and randomization.

All AF ablation procedures will be performed in a standard fashion, under general anaesthesia and with continuous esophageal temperature monitoring using a sinusoidal multi-sensor esophageal temperature probe (CIRCAtemp). After LA geometry reconstruction using 3-dimensional electroanatomical mapping EnSite Velocity and a multipolar circular mapping catheter St Jude Medical Optima, the ablation catheter Endosense Tacticath through a deflectable sheath St Medical Agilis will be used for Pulmonary Vein Isolation (PVI). Standardized RF settings will be used during ablation on the LA anterior wall as current practice in our centre. Different RF settings will be used on the LA posterior wall, according to randomization group. Moreover target values will be chosen for Lesion Size Index (LSI), a parameter useful to predict the lesion depth, during ablation on LA posterior wall. The duration of RF delivery on the LA posterior wall will be dictated by achievement of the target LSI or esophageal temperature rise > 39◦C during ablation. PVI will be achieved and confirmed after 30 minutes waiting time. In case of acute PV reconnection, ablation at sites of breakthrough signals will be performed in order to achieve durable PVI. The occurrence of acute PV reconnection (PVR) with sites of breakthrough signals on the LA posterior wall will be recorded for each procedure. The total procedure and RF ablation times will be also collected.

After the ablation, before discharge the symptoms status and heart rhythm will be assessed and the patient will be instructed to commence a symptoms diary. Telephone follow-ups will be then performed at 3 and 6 months to assess current symptom status. Standard care follow-up Arrhythmia Clinic visits will be also performed 3-4 months after the ablation procedure. Ad hoc visits and/or additional investigations as prolonged electrocardiogram (ECG) monitoring will also take place, dictated by arrhythmia symptoms and assessment for potential adverse events related to the procedure, in accordance with standard practice.

The end of the study for each patient will be the date of the 6 months telephone follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Power, Lesion Size Index and Oesophageal Temperature Alerts During Atrial Fibrillation Ablation: A Pilot Study
Study Start Date : January 2016
Actual Primary Completion Date : March 11, 2017
Actual Study Completion Date : March 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group "20 W / LSI 4"
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Procedure: Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
20 W RF power and target LSI = 4 on LA posterior wall

Active Comparator: Group "40 W / LSI 4"
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Procedure: Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
40 W RF power and target LSI = 4 on LA posterior wall

Active Comparator: Group "20 W / LSI 5"
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Procedure: Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
20 W RF power and target LSI = 5 on LA posterior wall

Active Comparator: Group "40 W / LSI 5"
Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
Procedure: Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
40 W RF power and target LSI = 5 on LA posterior wall




Primary Outcome Measures :
  1. Rate of Oesophageal Temperature Alerts During Radiofrequency Energy (RF) Ablation on the Left Atrial (LA) Posterior Wall [ Time Frame: 1 day ]
    Number of patients with luminal oesophageal temperature rises > 39◦C during radiofrequency (RF) ablation on the left atrial (LA) posterior wall

  2. Oesophageal Temperature Alerts Per Patient [ Time Frame: 1 day ]
    Number of oesophageal temperature alerts per patient


Secondary Outcome Measures :
  1. Rate of First-pass Pulmonary Vein Isolation (PVI) [ Time Frame: 1 day ]
    Rate of Pulmonary Veins (PVs) isolated after completion of first Pulmonary Vein Encirclement

  2. Rate of Acute Pulmonary Vein Reconnection (PVR) [ Time Frame: 1 day ]
    Number of pulmonary veins acutely reconnected after catheter ablation and isolation

  3. Total Procedure Time [ Time Frame: 1 day ]
    Total duration of the procedure

  4. Total Radiofrequency Energy (RF) Time for Pulmonary Vein Isolation (PVI) [ Time Frame: 1 day ]
    Total duration of radiofrequency energy required to achieve electrical isolation of the pulmonary veins

  5. Freedom From Atrial Fibrillation [ Time Frame: 6 months after the procedure ]
    Absence of symptoms suggestive of atrial fibrillation and no documentation of atrial fibrillation during the follow-up period

  6. Esophageal Symptoms After the Atrial Fibrillation (AF) Ablation [ Time Frame: 6 months after the procedure ]
    Difficult or painful swallowing, heartburn, acid reflux, sore throat, hoarseness, cough, nausea, vomiting, non-cardiac chest pain


Other Outcome Measures:
  1. Procedural Complications [ Time Frame: 1 day ]
    Pericardial effusion, transient ischemic attack/stroke, phrenic nerve injury, pulmonary vein stenosis, open-heart surgery, death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02619396


Locations
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United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Tim R Betts, MD Oxford University Hospitals NHS Trust
  Study Documents (Full-Text)

Documents provided by Dr Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust:
Publications:
Haines DE. Determinants of lesion size during radiofrequency catheter ablation: the role of electrode-tissue contact pressure and duration of energy delivery. Journal of Cardiovascular Electrophysiology. 2008;2(6):509-15.
Kautzner J, Neuzil P, Peickl P. Contact force, FTI and Lesion continuity are critical to improve durable PV isolation: EFFICAS 2 results. Heart Rhythm. 2012;9(5S):1-564

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Responsible Party: Dr Tim Betts MD MBChB FRCP, Consultant Cardiologist and Electrophysiologist, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02619396    
Other Study ID Numbers: 11536-SPON
First Posted: December 2, 2015    Key Record Dates
Results First Posted: July 8, 2020
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust:
radiofrequency power
lesion size index
esophageal temperature alerts
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes