Laura Valverde Soria, Jorge Toquero, Thomas Brouzet, Laura García Cano, Ana García Barrios, Melodie Segura Domínguez, Gloria A Hermón Ramírez, Raquel Ajo Ferrer, María Ajo Ferrer, Celia María Andreu Concha, Vicente Arrarte Esteban, Angel Sánchez Barbié, Juan Gabriel Martínez-Martínez, Alicia Ibáñez Criado, José Luis Ibáñez Criado
{"title":"高频短时间射频消融术治疗典型心房扑动：FASD-HP随机试验的基本原理和设计","authors":"Laura Valverde Soria, Jorge Toquero, Thomas Brouzet, Laura García Cano, Ana García Barrios, Melodie Segura Domínguez, Gloria A Hermón Ramírez, Raquel Ajo Ferrer, María Ajo Ferrer, Celia María Andreu Concha, Vicente Arrarte Esteban, Angel Sánchez Barbié, Juan Gabriel Martínez-Martínez, Alicia Ibáñez Criado, José Luis Ibáñez Criado","doi":"10.1007/s10840-024-01969-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The aim of cavotricuspid isthmus (CTI)-dependent flutter ablation is the bidirectional conduction block of the CTI. Very-high-power short-duration (vHPSD) radiofrequency ablation aims to minimize conductive heating and increase resistive heating to create shallower but wider lesions in a very short time, while reducing the risk of collateral tissue damage. Experimental studies have shown that it produces effective transmural lesions with an equal or better safety profile compared to conventional parameters. There are published and ongoing trials studying long-term outcomes of this technique for pulmonary vein isolation, but there is a lack of evidence regarding its use in flutter ablation.</p><p><strong>Methods and results: </strong>Multicenter 1:1 randomized, single-blind study. Two CTI ablation strategies are compared: (1) conventional treatment arm consisting of 25-40-W applications of unlimited duration until reaching the minimum value of one of the currently accepted lesion markers (Ablation Index > 500 at the anterior half of the CTI and > 400 at the posterior half with CARTO3 system); (2) experimental treatment arm consisting of CTI block using point-by-point applications of very-high-power (90 W) short duration (4 s). The primary objective is to evaluate the non-inferiority of the efficacy and safety of vHPSD ablation in patients undergoing typical flutter ablation. Secondary objectives include comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure, and time to flutter recurrence.</p><p><strong>Conclusions: </strong>The FASD-HP trial is the first clinical trial to investigate the non-inferiority of CTI ablation with vHPSD in patients with typical atrial flutter.</p><p><strong>Clinical trial registration number: </strong>The study was registered at http://www.</p><p><strong>Clinicaltrials: </strong>gov (NCT05777850) on March 21, 2023.</p>","PeriodicalId":16202,"journal":{"name":"Journal of Interventional Cardiac Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Very high-power short-duration radiofrequency ablation in patients with typical atrial flutter: rationale and design of the FASD-HP randomized trial.\",\"authors\":\"Laura Valverde Soria, Jorge Toquero, Thomas Brouzet, Laura García Cano, Ana García Barrios, Melodie Segura Domínguez, Gloria A Hermón Ramírez, Raquel Ajo Ferrer, María Ajo Ferrer, Celia María Andreu Concha, Vicente Arrarte Esteban, Angel Sánchez Barbié, Juan Gabriel Martínez-Martínez, Alicia Ibáñez Criado, José Luis Ibáñez Criado\",\"doi\":\"10.1007/s10840-024-01969-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The aim of cavotricuspid isthmus (CTI)-dependent flutter ablation is the bidirectional conduction block of the CTI. Very-high-power short-duration (vHPSD) radiofrequency ablation aims to minimize conductive heating and increase resistive heating to create shallower but wider lesions in a very short time, while reducing the risk of collateral tissue damage. Experimental studies have shown that it produces effective transmural lesions with an equal or better safety profile compared to conventional parameters. There are published and ongoing trials studying long-term outcomes of this technique for pulmonary vein isolation, but there is a lack of evidence regarding its use in flutter ablation.</p><p><strong>Methods and results: </strong>Multicenter 1:1 randomized, single-blind study. Two CTI ablation strategies are compared: (1) conventional treatment arm consisting of 25-40-W applications of unlimited duration until reaching the minimum value of one of the currently accepted lesion markers (Ablation Index > 500 at the anterior half of the CTI and > 400 at the posterior half with CARTO3 system); (2) experimental treatment arm consisting of CTI block using point-by-point applications of very-high-power (90 W) short duration (4 s). The primary objective is to evaluate the non-inferiority of the efficacy and safety of vHPSD ablation in patients undergoing typical flutter ablation. 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Very high-power short-duration radiofrequency ablation in patients with typical atrial flutter: rationale and design of the FASD-HP randomized trial.
Background: The aim of cavotricuspid isthmus (CTI)-dependent flutter ablation is the bidirectional conduction block of the CTI. Very-high-power short-duration (vHPSD) radiofrequency ablation aims to minimize conductive heating and increase resistive heating to create shallower but wider lesions in a very short time, while reducing the risk of collateral tissue damage. Experimental studies have shown that it produces effective transmural lesions with an equal or better safety profile compared to conventional parameters. There are published and ongoing trials studying long-term outcomes of this technique for pulmonary vein isolation, but there is a lack of evidence regarding its use in flutter ablation.
Methods and results: Multicenter 1:1 randomized, single-blind study. Two CTI ablation strategies are compared: (1) conventional treatment arm consisting of 25-40-W applications of unlimited duration until reaching the minimum value of one of the currently accepted lesion markers (Ablation Index > 500 at the anterior half of the CTI and > 400 at the posterior half with CARTO3 system); (2) experimental treatment arm consisting of CTI block using point-by-point applications of very-high-power (90 W) short duration (4 s). The primary objective is to evaluate the non-inferiority of the efficacy and safety of vHPSD ablation in patients undergoing typical flutter ablation. Secondary objectives include comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure, and time to flutter recurrence.
Conclusions: The FASD-HP trial is the first clinical trial to investigate the non-inferiority of CTI ablation with vHPSD in patients with typical atrial flutter.
Clinical trial registration number: The study was registered at http://www.
Clinicaltrials: gov (NCT05777850) on March 21, 2023.
期刊介绍：
The Journal of Interventional Cardiac Electrophysiology is an international publication devoted to fostering research in and development of interventional techniques and therapies for the management of cardiac arrhythmias. It is designed primarily to present original research studies and scholarly scientific reviews of basic and applied science and clinical research in this field. The Journal will adopt a multidisciplinary approach to link physical, experimental, and clinical sciences as applied to the development of and practice in interventional electrophysiology. The Journal will examine techniques ranging from molecular, chemical and pharmacologic therapies to device and ablation technology. Accordingly, original research in clinical, epidemiologic and basic science arenas will be considered for publication. Applied engineering or physical science studies pertaining to interventional electrophysiology will be encouraged. The Journal is committed to providing comprehensive and detailed treatment of major interventional therapies and innovative techniques in a structured and clinically relevant manner. It is directed at clinical practitioners and investigators in the rapidly growing field of interventional electrophysiology. The editorial staff and board reflect this bias and include noted international experts in this area with a wealth of expertise in basic and clinical investigation. Peer review of all submissions, conflict of interest guidelines and periodic editorial board review of all Journal policies have been established.
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