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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.
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 > 39â—¦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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall | Procedure | 20 W RF power and target LSI = 4 on LA posterior wall |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 > 39â—¦C during radiofrequency (RF) ablation on the left atrial (LA) posterior wall | 1 day |
| Oesophageal Temperature Alerts Per Patient | Number of oesophageal temperature alerts per patient | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of First-pass Pulmonary Vein Isolation (PVI) | Rate of Pulmonary Veins (PVs) isolated after completion of first Pulmonary Vein Encirclement | 1 day |
| Rate of Acute Pulmonary Vein Reconnection (PVR) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Complications | Pericardial effusion, transient ischemic attack/stroke, phrenic nerve injury, pulmonary vein stenosis, open-heart surgery, death | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim R Betts, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10666748 | Background | 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. | |
| Background | 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. | ||
| Background | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Group "20 W / LSI 4" | Patients elected to AF ablation and randomized to Combination 1 of RF power and LSI on LA posterior wall Combination 1 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall |
| FG001 | Group "40 W / LSI 4" |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2016 |
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| Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall | Procedure | 40 W RF power and target LSI = 4 on LA posterior wall |
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| Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall | Procedure | 20 W RF power and target LSI = 5 on LA posterior wall |
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| Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall | Procedure | 40 W RF power and target LSI = 5 on LA posterior wall |
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Number of pulmonary veins acutely reconnected after catheter ablation and isolation
| 1 day |
| Total Procedure Time | Total duration of the procedure | 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 | 1 day |
| Freedom From Atrial Fibrillation | Absence of symptoms suggestive of atrial fibrillation and no documentation of atrial fibrillation during the follow-up period | 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 | 6 months after the procedure |
| Background |
| 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. |
| 19808410 | Background | Singh 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. |
| 22381429 | Background | Kowalski 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. |
| 32898435 | Derived | Leo 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. |
Patients elected to AF ablation and randomized to Combination 2 of RF power and LSI on LA posterior wall Combination 2 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall |
| FG002 | Group "20 W / LSI 5" | Patients elected to AF ablation and randomized to Combination 3 of RF power and LSI on LA posterior wall Combination 3 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall |
| FG003 | Group "40 W / LSI 5" | Patients elected to AF ablation and randomized to Combination 4 of RF power and LSI on LA posterior wall Combination 4 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group "20 W / LSI 4" | Patients elected to AF ablation and randomized to Combination 1 of RF power and Lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall |
| BG001 | Group "40 W / LSI 4" | Patients elected to AF ablation and randomized to Combination 2 of RF power and Lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall |
| BG002 | Group "20 W / LSI 5" | Patients elected to AF ablation and randomized to Combination 3 of RF power and Lesion Size Index (LSI) on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall |
| BG003 | Group "40 W / LSI 5" | Patients elected to AF ablation and randomized to Combination 4 of RF power and Lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Paroxysmal atrial fibrillation (AF) | Count of Participants | Participants |
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| Atrial fibrillation (AF) history duration (months) | Median | Inter-Quartile Range | months |
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| Body Mass Index (BMI) | Mean | Standard Deviation | BMI unit = kg/m^2 |
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| Left atrial (LA) size | Mean | Standard Deviation | diameter (mm) |
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| Left ventricular (LV) function | Mean | Standard Deviation | LVEF (%) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 > 39â—¦C during radiofrequency (RF) ablation on the left atrial (LA) posterior wall | Posted | Count of Participants | Participants | 1 day |
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| Primary | Oesophageal Temperature Alerts Per Patient | Number of oesophageal temperature alerts per patient | Posted | Median | Inter-Quartile Range | oesophageal temperature alerts | 1 day |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Rate of First-pass Pulmonary Vein Isolation (PVI) | Rate of Pulmonary Veins (PVs) isolated after completion of first Pulmonary Vein Encirclement | 80 pulmonary veins in each group (4 veins per patient, 20 patients) | Posted | Number | pulmonary veins | 1 day | number of pulmonary veins in each group | number of pulmonary veins in each group |
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| Secondary | Rate of Acute Pulmonary Vein Reconnection (PVR) | Number of pulmonary veins acutely reconnected after catheter ablation and isolation | 80 pulmonary veins in each group (4 veins per patient, 20 patients) | Posted | Number | pulmonary veins | 1 day | number of pulmonary veins in each group | number of pulmonary veins in each group |
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| Secondary | Total Procedure Time | Total duration of the procedure | Posted | Median | Inter-Quartile Range | minutes | 1 day |
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| Secondary | Total Radiofrequency Energy (RF) Time for Pulmonary Vein Isolation (PVI) | Total duration of radiofrequency energy required to achieve electrical isolation of the pulmonary veins | Patients/ablation procedures per group | Posted | Median | Inter-Quartile Range | minutes | 1 day |
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| Secondary | Freedom From Atrial Fibrillation | Absence of symptoms suggestive of atrial fibrillation and no documentation of atrial fibrillation during the follow-up period | Patients per group | Posted | Count of Participants | Participants | 6 months after the procedure |
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| Secondary | 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 | Patients per group | Posted | Count of Participants | Participants | 6 months after the procedure |
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| Other Pre-specified | Procedural Complications | Pericardial effusion, transient ischemic attack/stroke, phrenic nerve injury, pulmonary vein stenosis, open-heart surgery, death | Posted | Count of Participants | Participants | 1 day |
|
6 months
Regular investigator assessment before discharge after catheter ablation and at subsequent telephone follow-ups
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group "20 W / LSI 4" | Patients elected to AF ablation and randomized to Combination 1 of RF power and LSI on LA posterior wall Combination 1 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 4 on LA posterior wall | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Group "40 W / LSI 4" | Patients elected to AF ablation and randomized to Combination 2 of RF power and LSI on LA posterior wall Combination 2 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 4 on LA posterior wall | 0 | 20 | 1 | 20 | 0 | 20 |
| EG002 | Group "20 W / LSI 5" | Patients elected to AF ablation and randomized to Combination 3 of RF power and LSI on LA posterior wall Combination 3 of RF power and LSI on LA posterior wall: 20 W RF power and target LSI = 5 on LA posterior wall | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Group "40 W / LSI 5" | Patients elected to AF ablation and randomized to Combination 4 of RF power and LSI on LA posterior wall Combination 4 of RF power and LSI on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall | 0 | 20 | 1 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Milena Leo | John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust | 0186522055 | milena.leo@ouh.nhs.uk |
| Feb 19, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000081982 | Laser Speckle Contrast Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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| OG003 | Group "40 W / LSI 5" | Patients elected to atrial fibrillation (AF) ablation and randomized to Combination 4 of radiofrequency energy (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall Combination 4 of radiofrequency energy (RF) power and lesion Size Index (LSI) on LA posterior wall: 40 W RF power and target LSI = 5 on LA posterior wall |
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