Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium

NCT05812261 | Completed DMC

• 1 other identifier: WO.23.038
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins. The main question it aims to answer is: In which percentage of the patients will pulsed field ablation result in successful isolation of the left common ostium? Nineteen patients will be prospectively included in OLVG. All patients will be treated with pulsed-field ablation (routine care). After the ablation procedure, an electro-anatomical map will be created using the ablation catheter and a mapping system. This map will display the left atrium and the lesion in detail. After the procedure, three experienced operators are asked to draw a line around the LCO in the anatomical map where they would have ablated if conventional radiofrequency ablation was used. The distance between the drawn line and the ablation lesion will be measured at three predefined points. The lesion is considered successful if the mean distance is within ±10mm at all measurement points.

Conditions

Atrial Fibrillation; Pulmonary Vein Isolation; Ablation Therapy

Keywords

Atrial fibrillation; Pulmonary vein isolation; Left common ostium; Pulsed-field ablation

Outcome Measures

Primary Outcomes (1)

• Successful left common ostium isolation after pulsed-field ablation in patients with atrial fibrillation

  The distance between the lesion and the line drawn in the electro-anatomical map by three operators will be measured at three predefined points. The lesion is considered successful if the mean distance is within 10mm at all points.

  Within one week after the procedure

Secondary Outcomes (7)

• Successful isolation at each measuring point

  Within one week after the procedure

• Distance between the left and right lesion

  Within one week after the procedure

• Correlation between posterior wall conduction speed and the left and right lesion distance

  Within one week after the procedure

• Safety outcomes within the hospital stay

  24 hours

• Number of patients with successful same-day discharge

  24 hours

Interventions

Creating an electro-anatomical map OTHER

After the routine pulsed-field ablation procedure, the operator will create an electro-anatomical map using the ablation catheter and a 3D mapping system.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation and a common ostium of the left pulmonary veins admitted and accepted for pulsed-field ablation at OLVG, Amsterdam, will be enrolled if eligible.

You may qualify if:

• Age \> 18 years of age on the day of enrolment of either sex
• Willing to the sign informed consent
• Left atrial volume index measured \< 60 ml/m2 within last 12 months
• Documented atrial fibrillation
• Admitted and accepted for PVI
• A left common ostium of the pulmonary veins identified by CT or MRI
• Accepted to receive general anaesthesia

You may not qualify if:

• Patients aged \< 18
• Body mass index \> 35kg/m2
• Left atrial volume index ≥ 60 ml/m2 within 12 months on MRI or cardiac echo
• New York Heart Association heart failure class III or IV
• Myocardial infarction within three months before the procedure
• Unstable angina pectoris
• Percutaneous coronary interventions within three months before the procedure
• Sudden cardiac death event within three months before the procedure
• A life expectancy of less than one year
• Presence of an atrial tachycardia other than cavotricuspid isthmus-dependent atrial flutter
• History of blood clotting or bleeding abnormalities
• History of a thromboembolic event within six months before the procedure
• A contraindication to anticoagulant
• Clinical significant infection
• Unstable clinical significant medical condition

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead
• OLVG: collaborator

Study Sites (1)

OLVG

Amsterdam, North Holland, 1091AC, Netherlands

Location

Related Publications (13)

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  PMID: 23900699 BACKGROUND

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• Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.

  PMID: 30874766 BACKGROUND

• Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, Poole JE, Rosenberg Y, Lee KL, Packer DL; CABANA Investigators. Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1275-1285. doi: 10.1001/jama.2019.0692.

  PMID: 30874716 BACKGROUND

• Andrade JG, Champagne J, Dubuc M, Deyell MW, Verma A, Macle L, Leong-Sit P, Novak P, Badra-Verdu M, Sapp J, Mangat I, Khoo C, Steinberg C, Bennett MT, Tang ASL, Khairy P; CIRCA-DOSE Study Investigators. Cryoballoon or Radiofrequency Ablation for Atrial Fibrillation Assessed by Continuous Monitoring: A Randomized Clinical Trial. Circulation. 2019 Nov 26;140(22):1779-1788. doi: 10.1161/CIRCULATIONAHA.119.042622. Epub 2019 Oct 21.

  PMID: 31630538 BACKGROUND

• Mol D, Boersma AM, Berger WR, Khan M, de Ruiter GS, Kimman GP, de Groot JR, de Jong JSSG. Intermediate-term outcome of cryoballoon ablation of persistent atrial fibrillation and improvements in quality of life of patients. PLoS One. 2022 Jan 21;17(1):e0261841. doi: 10.1371/journal.pone.0261841. eCollection 2022.

  PMID: 35061716 BACKGROUND

• Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

  PMID: 25946280 BACKGROUND

• Tondo C, Iacopino S, Pieragnoli P, Molon G, Verlato R, Curnis A, Landolina M, Allocca G, Arena G, Fassini G, Sciarra L, Luzi M, Manfrin M, Padeletti L; ClinicalService 1STOP Project Investigators. Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. Heart Rhythm. 2018 Mar;15(3):363-368. doi: 10.1016/j.hrthm.2017.10.038. Epub 2017 Oct 26.

  PMID: 29107190 BACKGROUND

• Mansour M, Holmvang G, Sosnovik D, Migrino R, Abbara S, Ruskin J, Keane D. Assessment of pulmonary vein anatomic variability by magnetic resonance imaging: implications for catheter ablation techniques for atrial fibrillation. J Cardiovasc Electrophysiol. 2004 Apr;15(4):387-93. doi: 10.1046/j.1540-8167.2004.03515.x.

  PMID: 15089984 BACKGROUND

• Ronsoni RM, Silvestrini TL, Saffi MAL, Leiria TLL. Impact of the left common ostium following pulmonary vein isolation in AF: Systematic review and meta-analysis. J Arrhythm. 2022 Apr 5;38(3):287-298. doi: 10.1002/joa3.12710. eCollection 2022 Jun.

  PMID: 35785389 BACKGROUND

• Proietti R, Santangeli P, Di Biase L, Joza J, Bernier ML, Wang Y, Sagone A, Viecca M, Essebag V, Natale A. Comparative effectiveness of wide antral versus ostial pulmonary vein isolation: a systematic review and meta-analysis. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):39-45. doi: 10.1161/CIRCEP.113.000922. Epub 2014 Jan 2.

  PMID: 24385448 BACKGROUND

• Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

  PMID: 33933412 BACKGROUND

• Sorensen SK, Johannessen A, Worck R, Hansen ML, Hansen J. Radiofrequency Versus Cryoballoon Catheter Ablation for Paroxysmal Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Effect on Atrial Fibrillation Burden: The RACE-AF Randomized Controlled Trial. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009573. doi: 10.1161/CIRCEP.120.009573. Epub 2021 Apr 9.

  PMID: 33835823 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Mol, PhD

  OLVG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 13, 2023
• Study Start: July 19, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

NL (1)