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

NCT02619396 | Completed Results

• 1 other identifier: 11536-SPON
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

radiofrequency power; lesion size index; esophageal temperature alerts

Outcome Measures

Primary Outcomes (2)

• 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

  1 day

• Oesophageal Temperature Alerts Per Patient

  Number of oesophageal temperature alerts per patient

  1 day

Secondary Outcomes (6)

• Rate of First-pass Pulmonary Vein Isolation (PVI)

  1 day

• Rate of Acute Pulmonary Vein Reconnection (PVR)

  1 day

• Total Procedure Time

  1 day

• Total Radiofrequency Energy (RF) Time for Pulmonary Vein Isolation (PVI)

  1 day

• Freedom From Atrial Fibrillation

  6 months after the procedure

Other Outcomes (1)

• Procedural Complications

  1 day

Study Arms (4)

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

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

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

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

Procedure: Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall

Interventions

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

Group "20 W / LSI 4"

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

Group "40 W / LSI 4"

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

Group "20 W / LSI 5"

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

Group "40 W / LSI 5"

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 10666748 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

  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.

  PMID: 16027254 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.

  PMID: 19808410 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.

  PMID: 22381429 BACKGROUND

• 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.

  PMID: 32898435 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Dr Milena Leo
• Organization: John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust

milena.leo@ouh.nhs.uk

0186522055

Study Officials

• Tim R Betts, MD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist and Electrophysiologist

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: December 2, 2015
• Study Start: January 1, 2016
• Primary Completion: March 11, 2017
• Study Completion: March 11, 2017
• Last Updated: July 8, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)