Andrade Jason G, Deyell Marc W, Badra Mariano, Champagne Jean, Dubuc Marc, Leong-Sit Peter, Macle Laurent, Novak Paul, Roux Jean-Francois, Sapp John, Tang Anthony, Verma Atul, Wells George A, Khairy Paul
Department of Medicine, Montreal Heart Institute, Université de Montréal, British Columbia, Canada.
Department of Medicine, University of British Columbia, Montreal, Quebec, Canada.
BMJ Open. 2017 Oct 5;7(10):e017970. doi: 10.1136/bmjopen-2017-017970.
Pulmonary vein isolation (PVI) is an effective therapy for paroxysmal atrial fibrillation (AF), but it has limitations. The two most significant recent advances have centred on the integration of real-time quantitative assessment of catheter contact force into focal radio frequency (RF) ablation catheters and the development of dedicated ablation tools capable of achieving PVI with a single ablation lesion (Arctic Front cryoballoon, Medtronic, Minneapolis, MN, USA). Although each of these holds promise for improving the clinical success of catheter ablation of AF, there has not been a rigorous comparison of these advanced ablation technologies. Moreover, the optimal duration of cryoablation (freezing time) has not been determined.
Patients undergoing an initial PVI procedure for paroxysmal AF will be recruited. Patients will be randomised 1:1:1 between contact-force irrigated RF ablation, short duration cryoballoon ablation (2 min applications) and standard duration cryoballoon ablation (4 min applications). The primary outcome is time to first documented AF recurrence on implantable loop recorder. With a sample size of 111 per group and a two-sided 0.025 significance level (to account for the two main comparisons), the study will have 80% power (using a log-rank test) to detect a difference of 20% between contact force RF catheter ablation and either of the two cryoballoon ablation groups. Factoring in a 4% loss to follow-up, 116 patients per group should be randomised and followed for a year (total study population of 348).
The study was approved by the University of British Columbia Office of Research (Services) Ethics Clinical Research Ethics Board. Results of the study will be submitted for publication in a peer-reviewed journal.
NCT01913522; Pre-results.
肺静脉隔离术（PVI）是阵发性心房颤动（AF）的一种有效治疗方法，但存在局限性。近期两项最重要的进展集中在将导管接触力的实时定量评估整合到局灶性射频（RF）消融导管中，以及开发能够通过单次消融病变实现肺静脉隔离的专用消融工具（北极星冷冻球囊，美敦力公司，美国明尼阿波利斯，MN）。尽管这些进展都有望提高房颤导管消融的临床成功率，但尚未对这些先进的消融技术进行严格比较。此外，冷冻消融的最佳持续时间（冷冻时间）尚未确定。
将招募因阵发性房颤首次接受肺静脉隔离术的患者。患者将按1:1:1随机分为接触力灌注射频消融组、短时间冷冻球囊消融组（应用2分钟）和标准时间冷冻球囊消融组（应用4分钟）。主要结局是植入式环形记录仪首次记录到房颤复发的时间。每组样本量为111例，双侧显著性水平为0.025（考虑两项主要比较），该研究将有80%的把握度（使用对数秩检验）检测接触力射频导管消融与两个冷冻球囊消融组中任一组之间20%的差异。考虑到4%的失访率，每组应随机分配116例患者并随访一年（总研究人群为348例）。
该研究已获得英属哥伦比亚大学研究（服务）伦理临床研究伦理委员会的批准。研究结果将提交至同行评审期刊发表。
NCT01913522；预结果。
