AF Ablation With High Power Short Duration RF

Официальное название

Atrial Fibrillation Ablation by Means of Very High Power Short Duration (AIR HPSD Registry)

Обзор

This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF). Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters). Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD. At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R\^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.

Подробное описание

Patients will be screened in ambulatory and scheduled for AF ablation according to current guidelines. Ablation will be usually performed under effective oral anticoagulation. Anticoagulation could be withdrawn before admission, so as antiarrhythmic drugs will be removed before scheduled procedure. Patients in AF or with a CHA2DS2-VASc score ≥ 1 will undergo transesophageal echocardiography within 48 hours prior to the ablation. For all other patients transesophageal echocardiography is optional. Cardiac MRI or Cardiac CT scan could be executed as a reference for volume estimations obtained with the mapping system.

Ablation will be carried out under mild or deep sedation, or general anesthesia according to center preference. At least 2 femoral vein access will be obtained and in some patients 1 subclavian vein. One diagnostic catheter will be positioned in the coronary sinus. One or two transseptal accesses to the left atrium will be achieved using a standard approach. Then, the mapping catheter (LASSO, Penta-ray, Octa-ray catheter) and the ablation catheter (QDot Micro catheter) will be placed in the left atrium. Heparin will be administered before the transseptal punctures to maintain an activated clotting time ≥ 300 seconds for the duration of the procedure. Left atrium mapping will be performed in sinus rhythm. Patients with atrial fibrillation at the beginning of the index procedure will undergo electrical cardioversion. After left atrium reconstruction the effective PV-left atrium electrical connection will be checked with the mapping catheter. In all patients a wide antrum circumferential ablation aimed at PV isolation will be performed using the QDot Micro catheter in QMode+ mode (90 w for 4 sec) for the whole ablation or in an hybrid mode (QMode + for posterior wall and QMode guided by AI in the anterior wall), according to the operator preference. The maximum interlesion distance will be \<6 mm (16,17). According to operator preference it will be performed an ablation line encircling each PV or two ablation lines encircling the right and the left PVs. At the end of the ablation effective PV isolation (entry and exit block), will be checked with mapping catheter. After PV isolation will be achieved, the reconnection of the same vein will be evaluated after a 20 minute period from the initial isolation or after adenosine infusion or isoproterenol. If the vein reconnects to the atrium, the ablation will be directed to the gaps identified by the mapping catheter.

All patients will undergo a post-procedural ECG and, optional, an echocardiogram to exclude pericardial effusion or other acute complications.

After ablation, patients will undertake regular follow-up assessments (scheduled at 3 months) including a detailed history, physical examination, 12-lead standard electrocardiography, and 24-h Holter monitoring. Patients who will not report any symptoms related to the previous arrhythmia during a supplementary detailed follow up (6-12 months subsequent to catheter ablation) will be considered free of arrhythmia recurrence

Первичные конечные точки

• Association between clinical and procedural characteristics and the percentage of arrhythmia recurrence rate after PV isolation performed with HPSD. [Срок оценки: 12 months after ablation]

Вторичные конечные точки (7)

• Percentage of acute pulmonary vein reconnection reconnection [Срок оценки: 20 minutes after ablation]
• Procedural time [Срок оценки: during the procedure]
• Percentage of patients with atrial arrhythmias recurrence during the blanking period [Срок оценки: 3 months after ablation]
• Impact of anaesthesia type [Срок оценки: during the procedure]
• Evaluation of pain perception during ablation [Срок оценки: during the procedure]
• Fluoroscopy time [Срок оценки: during the procedure]
• Radiofrequency time [Срок оценки: during the procedure]

Критерии участия

Критерии включения

• Patients with paroxysmal/persistent AF who signed the informed consent
• Patients on active oral anticoagulation

Критерии исключения

• Previous ablation for AF
• Patients with LVEF<35%
• Women potentially pregnant
• Contraindications to X-ray exposure
• Congenital heart disease or cardiac surgery within 1 month

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 7 центров

• Clinica Montevergine — Mercogliano
• Maria cecilia Hospital — Cotignola
• Ospedale di Conegliano — Conegliano
• Università Politecnica delle Marche — Ancona
• Ospedale Civile di Asti — Asti
• Clinica Mediterranea — Naples
• Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Univer — Torino

Франция · 1 центр

• Centre Cardiologique Du Nord — Paris

Великобритания · 1 центр

• Royal Papworth Hospital — Cambridge

Публикации

• Stabile G, Lepillier A, De Ruvo E, Scaglione M, Anselmino M, Sebag F, Pecora D, Gallagher M, Rillo M, Viola G, Rossi L, De Santis V, Landolina M, Castro A, Grimaldi M, Badenco N, Del Greco M, De Simone A, Pisano E, Abbey S, Lamberti F, Pani A, Zucchelli G, Sgarito G, Dugo D, Bertaglia E, Strisciuglio T, Solimene F. Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year ou PMID 32369225
• Duytschaever M, Vijgen J, De Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, Szeplaki G, Stevenhagen YJ, Taghji P, Wright M, Macours N, Gupta D. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial. Europace. 2020 Nov 1;22(11):1645-1652. doi: 10.1093/europace/euaa157. PMID 32879974
• Ouyang F, Antz M, Ernst S, Hachiya H, Mavrakis H, Deger FT, Schaumann A, Chun J, Falk P, Hennig D, Liu X, Bansch D, Kuck KH. Recovered pulmonary vein conduction as a dominant factor for recurrent atrial tachyarrhythmias after complete circular isolation of the pulmonary veins: lessons from double Lasso technique. Circulation. 2005 Jan 18;111(2):127-35. doi: 10.1161/01.CIR.0000151289.73085.36. Epub PMID 15623542
• Lemola K, Hall B, Cheung P, Good E, Han J, Tamirisa K, Chugh A, Bogun F, Pelosi F Jr, Morady F, Oral H. Mechanisms of recurrent atrial fibrillation after pulmonary vein isolation by segmental ostial ablation. Heart Rhythm. 2004 Jul;1(2):197-202. doi: 10.1016/j.hrthm.2004.03.071. PMID 15851153
• Cappato R, Negroni S, Pecora D, Bentivegna S, Lupo PP, Carolei A, Esposito C, Furlanello F, De Ambroggi L. Prospective assessment of late conduction recurrence across radiofrequency lesions producing electrical disconnection at the pulmonary vein ostium in patients with atrial fibrillation. Circulation. 2003 Sep 30;108(13):1599-604. doi: 10.1161/01.CIR.0000091081.19465.F1. Epub 2003 Sep 8. PMID 12963643
• Wang XH, Liu X, Sun YM, Gu JN, Shi HF, Zhou L, Hu W. Early identification and treatment of PV re-connections: role of observation time and impact on clinical results of atrial fibrillation ablation. Europace. 2007 Jul;9(7):481-6. doi: 10.1093/europace/eum101. Epub 2007 May 23. PMID 17522081
• McLellan AJ, Kumar S, Smith C, Morton JB, Kalman JM, Kistler PM. The role of adenosine following pulmonary vein isolation in patients undergoing catheter ablation for atrial fibrillation: a systematic review. J Cardiovasc Electrophysiol. 2013 Jul;24(7):742-51. doi: 10.1111/jce.12121. Epub 2013 Mar 14. PMID 23489944
• Leshem E, Zilberman I, Tschabrunn CM, Barkagan M, Contreras-Valdes FM, Govari A, Anter E. High-Power and Short-Duration Ablation for Pulmonary Vein Isolation: Biophysical Characterization. JACC Clin Electrophysiol. 2018 Apr;4(4):467-479. doi: 10.1016/j.jacep.2017.11.018. Epub 2018 Feb 2. PMID 30067486

Идентификаторы

NCT: NCT05777551 · AIR HPSD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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