INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation

Atrial Fibrillation Clinical Trial

— INSIDEPVs  

Official title:

INtra-procedural ultraSound Imaging for DEtermination of Atrial Wall Thickness and Acute Tissue Changes During Isolation of the Pulmonary Veins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372798
• Other study ID #: 12163-SPON
• Status: Completed
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2024
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall thickness and about its acute changes during energy delivery for ablation. This makes difficult to predict the achievement of transmural lesions, to identify the possible causes of ablation failure and also to avoid the occurrence of perforation and/or other collateral damage.

Computed tomography (CT) is a reliable technique for measurement of the LA wall thickness but it cannot be used during the ablation procedure and its extensive use is limited by the need of ionizing radiation. Preliminary data from animal studies support the accuracy of real-time ultrasound imaging modalities such as intracardiac echocardiography (ICE) or Intravascular Ultrasound (IVUS) imaging for measurement of LA wall thickness and monitoring of its acute changes related to catheter ablation.

The pilot study INSIDE PVs has been primarily designed to evaluate the feasibility and accuracy of intravascular imaging techniques for real-time imaging of the LA wall thickness during AF ablation.

Description:

Patients scheduled for their first pulmonary vein (PV) isolation ablation for symptomatic, drug-refractory paroxysmal atrial fibrillation (AF), will be considered for inclusion in the study.

Potential subjects will initially be approached some weeks before their ablation procedure, in order to give the patients enough time to consider the information, to ask questions to the Investigator, their general practitioner (GP) 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. Moreover, a pre-operative imaging assessment with a cardiac computed tomography (CT) scan will be performed to define the left atrial (LA) and PV anatomy and to measure the baseline LA wall thickness and PVs ostial diameters.

All AF ablation procedures will be performed in a standard fashion by using radiofrequency (RF) energy, cryo-balloon or laser balloon ablation under general anaesthesia and with continuous oesophageal temperature monitoring. Ultrasound imaging by IVUS (Visions PV .018, 20 MHz digital probe, Volcano Corp) or ICE (Ultra ICE (9 MHz rotational transducer, Boston Scientific) will be performed at sites corresponding with the PV/LA junction at the beginning and the end of the procedure in order to measure acute changes in LA wall thickness and PV ostial diameters.

The cardiac CT will be repeated within 24 hours post-procedure. After the procedure, a pre-discharge review and a telephone follow-up at 1 week will be performed to identify any early and late complications related to the procedure.

A total of 14 patients will finally be enrolled in the study. The end of the study for each patient will be the date of the telephone follow-up 1 week after the procedure.

For each patient the pre-procedural and post-procedural CT measurements of LA wall thickness and PVs ostial diameters will be compared with the corresponding IVUS or ICE measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

• Inclusion Criteria

• Males older than 40 years or females older than 40 and sterile or in post-menopausal age;

• willing and able to give informed consent for participation in the study;

• history of symptomatic and drug-refractory paroxysmal atrial fibrillation (AF);

• planned AF ablation on a clinical basis.

• Exclusion Criteria

• age less than 40 years and more than 80 years;

• pregnancy, trying for a baby or breast feeding;

• 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;

• documented allergy to iodinated contrast medium;

• renal insufficiency (eGFR<30);

• weight exceeding the maximum load of the scanner (250kg).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• ICE/IVUS imaging during atrial fibrillation ablation
Intravascular ultrasound imaging of the left atrial wall thickness with ICE/IVUS during atrial fibrillation ablation

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

Gage AA, Baust J. Mechanisms of tissue injury in cryosurgery. Cryobiology. 1998 Nov;37(3):171-86. doi: 10.1006/cryo.1998.2115. — View Citation

Granier M, Winum PF, Granier M, Liaud P, Cayla G, Messner P, Pasquie JL, Schuster I. Real-time atrial wall imaging during radiofrequency ablation in a porcine model. Heart Rhythm. 2015 Aug;12(8):1827-35. doi: 10.1016/j.hrthm.2015.04.012. Epub 2015 Apr 8. — View Citation

Hall B, Jeevanantham V, Simon R, Filippone J, Vorobiof G, Daubert J. Variation in left atrial transmural wall thickness at sites commonly targeted for ablation of atrial fibrillation. J Interv Card Electrophysiol. 2006 Nov;17(2):127-32. doi: 10.1007/s10840-006-9052-2. Epub 2007 Jan 17. — View Citation

Khairy P, Chauvet P, Lehmann J, Lambert J, Macle L, Tanguay JF, Sirois MG, Santoianni D, Dubuc M. Lower incidence of thrombus formation with cryoenergy versus radiofrequency catheter ablation. Circulation. 2003 Apr 22;107(15):2045-50. doi: 10.1161/01.CIR.0000058706.82623.A1. Epub 2003 Mar 31. — View Citation

Khairy P, Dubuc M. Transcatheter cryoablation part I: preclinical experience. Pacing Clin Electrophysiol. 2008 Jan;31(1):112-20. doi: 10.1111/j.1540-8159.2007.00934.x. No abstract available. — View Citation

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. — View Citation

Okada T, Yamada T, Murakami Y, Yoshida N, Ninomiya Y, Shimizu T, Toyama J, Yoshida Y, Ito T, Tsuboi N, Kondo T, Inden Y, Hirai M, Murohara T. Prevalence and severity of left atrial edema detected by electron beam tomography early after pulmonary vein ablation. J Am Coll Cardiol. 2007 Apr 3;49(13):1436-42. doi: 10.1016/j.jacc.2006.10.076. Epub 2007 Mar 21. — View Citation

Reddy VY, Neuzil P, Themistoclakis S, Danik SB, Bonso A, Rossillo A, Raviele A, Schweikert R, Ernst S, Kuck KH, Natale A. Visually-guided balloon catheter ablation of atrial fibrillation: experimental feasibility and first-in-human multicenter clinical outcome. Circulation. 2009 Jul 7;120(1):12-20. doi: 10.1161/CIRCULATIONAHA.108.840587. Epub 2009 Jun 22. — View Citation

Ren JF, Callans DJ, Schwartzman D, Michele JJ, Marchlinski FE. Changes in local wall thickness correlate with pathologic lesion size following radiofrequency catheter ablation: an intracardiac echocardiographic imaging study. Echocardiography. 2001 Aug;18(6):503-7. doi: 10.1046/j.1540-8175.2001.00503.x. — View Citation

Schwartzman D, Ren JF, Devine WA, Callans DJ. Cardiac swelling associated with linear radiofrequency ablation in the atrium. J Interv Card Electrophysiol. 2001 Jun;5(2):159-66. doi: 10.1023/a:1011477408021. — View Citation

Weerasooriya R, Jais P, Sanders P, Scavee C, Hsu LF, Hocini M, Clementy J, Haissaguerre M. Images in cardiovascular medicine. Early appearance of an edematous tissue reaction during left atrial linear ablation using intracardiac echo imaging. Circulation. 2003 Sep 16;108(11):e80. doi: 10.1161/01.CIR.0000083530.08597.B5. No abstract available. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames	Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = [(vessel area - lumen area)/vessel area] x 100	Day 1
Primary	Measurement of LA Wall Thickness on CT Scans	Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = [(vessel area - lumen area)/vessel area] x 100	1 day
Secondary	Mean Time Required for ICE/IVUS for Real Time Imaging of the Left Atrial (LA) Wall Thickness During AF Ablation	Mean time required to image the left atrium for measurement of left atrial wall thickness with intracardiac echo (ICE) or with intravascular ultrasound (IVUS)	Day 1
Secondary	Number of ICE/IVUS Cases of Good Quality	Number of intracardiac echo (ICE) cases and number of intravascular ultrasound (IVUS) cases of good quality, allowing a precise measurement of the left atrial (LA) wall thickness The imaging quality of each PV cross-section was defined as good quality if the vessel contour was visible in all 4 quadrants.	Day 1