Atrial FibrillationPiLOT-AFNCT02619396
RF Power, LSI and Oesophageal Temperature Alerts During AF Ablation (PiLOT-AF Study)
A study testing Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall and Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall and Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to 11 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiofrequency Power, Lesion Size Index and Oesophageal Temperature Alerts During Atrial Fibrillation Ablation: A Pilot Study
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.
Read more
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall
- Keywords
- radiofrequency power, lesion size index, esophageal temperature alerts
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallProcedure or surgery
20 W RF power and target LSI = 4 on LA posterior wall
Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallProcedure or surgery
40 W RF power and target LSI = 4 on LA posterior wall
Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallProcedure or surgery
20 W RF power and target LSI = 5 on LA posterior wall
Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallProcedure or surgery
40 W RF power and target LSI = 5 on LA posterior wall
| Study group | Role | What they receive |
|---|---|---|
| Group "20 W / LSI 4" | Active comparator | 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 Receives: Procedure: Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall |
| Group "40 W / LSI 4" | Active comparator | 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 Receives: Procedure: Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall |
| Group "20 W / LSI 5" | Active comparator | 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 Receives: Procedure: Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall |
| Group "40 W / LSI 5" | Active comparator | 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 Receives: Procedure: Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Oesophageal Temperature Alerts During Radiofrequency Energy (RF) Ablation on the Left Atrial (LA) Posterior Wall
Number of patients with luminal oesophageal temperature rises > 39◦C during radiofrequency (RF) ablation on the left atrial (LA) posterior wall
Measured: 1 day
Oesophageal Temperature Alerts Per Patient
Number of oesophageal temperature alerts per patient
Measured: 1 day
Secondary outcomes (6)
Rate of First-pass Pulmonary Vein Isolation (PVI)
Rate of Pulmonary Veins (PVs) isolated after completion of first Pulmonary Vein Encirclement
Measured: 1 day
Rate of Acute Pulmonary Vein Reconnection (PVR)
Number of pulmonary veins acutely reconnected after catheter ablation and isolation
Measured: 1 day
Total Procedure Time
Total duration of the procedure
Measured: 1 day
Total Radiofrequency Energy (RF) Time for Pulmonary Vein Isolation (PVI)
Total duration of radiofrequency energy required to achieve electrical isolation of the pulmonary veins
Measured: 1 day
Freedom From Atrial Fibrillation
Absence of symptoms suggestive of atrial fibrillation and no documentation of atrial fibrillation during the follow-up period
Measured: 6 months after the procedure
Esophageal Symptoms After the Atrial Fibrillation (AF) Ablation
Difficult or painful swallowing, heartburn, acid reflux, sore throat, hoarseness, cough, nausea, vomiting, non-cardiac chest pain
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion11 Mar 2017
- Study completion11 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust
- Investigators
- Tim R Betts, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619396
- Sponsor's protocol ID
- 11536-SPON
- Acronym
- PiLOT-AF
- Status last verified
- Jul 2020
- First submitted
- 26 Oct 2015
- Last updated
- 8 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Petersen HH, Chen X, Pietersen A, Svendsen JH, Haunso S. Tissue temperatures and lesion size during irrigated tip catheter radiofrequency ablation: an in vitro comparison of temperature-controlled irrigated tip ablation, power-controlled irrigated tip ablation, and standard temperature-controlled ablation. Pacing Clin Electrophysiol. 2000 Jan;23(1):8-17. doi: 10.1111/j.1540-8159.2000.tb00644.x.
PubMed 10666748Haines 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
Cummings JE, Schweikert RA, Saliba WI, Burkhardt JD, Brachmann J, Gunther J, Schibgilla V, Verma A, Dery M, Drago JL, Kilicaslan F, Natale A. Assessment of temperature, proximity, and course of the esophagus during radiofrequency ablation within the left atrium. Circulation. 2005 Jul 26;112(4):459-64. doi: 10.1161/CIRCULATIONAHA.104.509612. Epub 2005 Jul 18.
PubMed 16027254Singh SM, d'Avila A, Doshi SK, Brugge WR, Bedford RA, Mela T, Ruskin JN, Reddy VY. Esophageal injury and temperature monitoring during atrial fibrillation ablation. Circ Arrhythm Electrophysiol. 2008 Aug;1(3):162-8. doi: 10.1161/CIRCEP.107.789552.
PubMed 19808410Kowalski M, Grimes MM, Perez FJ, Kenigsberg DN, Koneru J, Kasirajan V, Wood MA, Ellenbogen KA. Histopathologic characterization of chronic radiofrequency ablation lesions for pulmonary vein isolation. J Am Coll Cardiol. 2012 Mar 6;59(10):930-8. doi: 10.1016/j.jacc.2011.09.076.
PubMed 22381429Leo M, Pedersen M, Rajappan K, Ginks MR, Hunter RJ, Bowers R, Kalla M, Bashir Y, Betts TR. Power, Lesion Size Index and Oesophageal Temperature Alerts During Atrial Fibrillation Ablation: A Randomized Study. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008316. doi: 10.1161/CIRCEP.120.008316. Epub 2020 Sep 8.
PubMed 32898435
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Power, Lesion Size Index and Oesophageal Temperature Alerts During Atrial Fibrillation Ablation: A Pilot Study
- ClinicalTrials.gov ID
- NCT02619396
- Acronym / sponsor ID
- PiLOT-AF / 11536-SPON
- Conditions
- Atrial Fibrillation
- Keywords
- radiofrequency power, lesion size index, esophageal temperature alerts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 11 Mar 2017 (actual)
- Study completion
- 11 Mar 2017 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Posted 8 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group "20 W / LSI 4" | Active comparator | Procedure: Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallPatients 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 |
| Group "40 W / LSI 4" | Active comparator | Procedure: Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallPatients 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 |
| Group "20 W / LSI 5" | Active comparator | Procedure: Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallPatients 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 |
| Group "40 W / LSI 5" | Active comparator | Procedure: Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wallPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall20 W RF power and target LSI = 4 on LA posterior wall | Procedure or surgery | Group "20 W / LSI 4" |
| Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall40 W RF power and target LSI = 4 on LA posterior wall | Procedure or surgery | Group "40 W / LSI 4" |
| Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall20 W RF power and target LSI = 5 on LA posterior wall | Procedure or surgery | Group "20 W / LSI 5" |
| Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall40 W RF power and target LSI = 5 on LA posterior wall | Procedure or surgery | Group "40 W / LSI 5" |
Primary outcome
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
Oesophageal Temperature Alerts Per Patient
Time frame: 1 day
Number of oesophageal temperature alerts per patient
6 secondary outcomes
Rate of First-pass Pulmonary Vein Isolation (PVI)
Time frame: 1 day
Rate of Acute Pulmonary Vein Reconnection (PVR)
Time frame: 1 day
Total Procedure Time
Time frame: 1 day
Total Radiofrequency Energy (RF) Time for Pulmonary Vein Isolation (PVI)
Time frame: 1 day
Freedom From Atrial Fibrillation
Time frame: 6 months after the procedure
Esophageal Symptoms After the Atrial Fibrillation (AF) Ablation
Time frame: 6 months after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10666748Petersen HH, Chen X, Pietersen A, Svendsen JH, Haunso S. Tissue temperatures and lesion size during irrigated tip catheter radiofrequency ablation: an in vitro comparison of temperature-controlled irrigated tip ablation, power-controlled irrigated tip ablation, and standard temperature-controlled ablation. Pacing Clin Electrophysiol. 2000 Jan;23(1):8-17. doi: 10.1111/j.1540-8159.2000.tb00644.x.
- BackgroundHaines 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.
- BackgroundKautzner 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
- Background: PubMed 16027254Cummings JE, Schweikert RA, Saliba WI, Burkhardt JD, Brachmann J, Gunther J, Schibgilla V, Verma A, Dery M, Drago JL, Kilicaslan F, Natale A. Assessment of temperature, proximity, and course of the esophagus during radiofrequency ablation within the left atrium. Circulation. 2005 Jul 26;112(4):459-64. doi: 10.1161/CIRCULATIONAHA.104.509612. Epub 2005 Jul 18.
- Background: PubMed 19808410Singh SM, d'Avila A, Doshi SK, Brugge WR, Bedford RA, Mela T, Ruskin JN, Reddy VY. Esophageal injury and temperature monitoring during atrial fibrillation ablation. Circ Arrhythm Electrophysiol. 2008 Aug;1(3):162-8. doi: 10.1161/CIRCEP.107.789552.
- Background: PubMed 22381429Kowalski M, Grimes MM, Perez FJ, Kenigsberg DN, Koneru J, Kasirajan V, Wood MA, Ellenbogen KA. Histopathologic characterization of chronic radiofrequency ablation lesions for pulmonary vein isolation. J Am Coll Cardiol. 2012 Mar 6;59(10):930-8. doi: 10.1016/j.jacc.2011.09.076.
- Derived from this study: PubMed 32898435Leo M, Pedersen M, Rajappan K, Ginks MR, Hunter RJ, Bowers R, Kalla M, Bashir Y, Betts TR. Power, Lesion Size Index and Oesophageal Temperature Alerts During Atrial Fibrillation Ablation: A Randomized Study. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008316. doi: 10.1161/CIRCEP.120.008316. Epub 2020 Sep 8.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim R Betts, MD principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall, Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall and Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Oesophageal Temperature Alerts During Radiofrequency Energy (RF) Ablation on the Left Atrial (LA) Posterior Wall (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619396, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.