Atrial Fibrillation Clinical Trial
— PFALCO RemapOfficial title:
Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium
NCT number | NCT05812261 |
Other study ID # | WO.23.038 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 19, 2023 |
Est. completion date | February 29, 2024 |
Verified date | March 2024 |
Source | Onze Lieve Vrouwe Gasthuis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | February 29, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Previous left atrium ablation, except successful accessory pathway ablation - Presence of a left appendage closure device - Presence of an atrial septum occluder - Presence of a prosthetic heart valve - Occlusion of the inferior venous tract - Enrolment in another study that would interfere with this study |
Country | Name | City | State |
---|---|---|---|
Netherlands | OLVG | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Onze Lieve Vrouwe Gasthuis | OLVG |
Netherlands,
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. — View Citation
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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. — View Citation
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. Erratum In: JAMA. 2019 Jun 18;321(23):2370. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Successful isolation at each measuring point | The mean distance between the lesion and line in the electro-anatomical map for each measuring point. (Superior roof, mid posterior, and inferior) | Within one week after the procedure | |
Secondary | Distance between the left and right lesion | Distance between the left and right lesion measured at the superior roof, mid posterior, and inferior | Within one week after the procedure | |
Secondary | Correlation between posterior wall conduction speed and the left and right lesion distance | Conduction speed at the posterior wall will be measured with an activation map. All the activation data will be collected simultaneously with the electro-anatomical map. | Within one week after the procedure | |
Secondary | Safety outcomes within the hospital stay | The occurrence of procedural-related complications, including:
Vascular complication (defined as a major or minor vascular complication from the Valve Academic Research Consortium-2) Bleeding complication (defined as Bleeding Academic Research Consortium type 2 or higher) Tamponade, for which an intervention is required Transient phrenic nerve palsy (lasting < 24 hours) Persistent phrenic nerve palsy (lasting = 24 hours) Thromboembolic event Admission for more than 24 hours post-procedure and the reason for prolonged admission. |
24 hours | |
Secondary | Number of patients with successful same-day discharge | The number of patients who were successfully discharged and data on hospital prolongation will be collected. | 24 hours | |
Secondary | Interoperator variability of the line drawn in the anatomical map | The investigators will investigate the variation of the line drawn by three operators | Within one week after the procedure | |
Secondary | True pulmonary vein isolation demonstrated with the Boston Farawave and Ensite Precision | Here the investigators will investigate whether all pulmonary veins are isolation based on the information from the electro-anatomical map. | During the procedure |
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