Minglong Chen1, Shulin Wu2, Yan Yao3, Jian Jiang4, Chenyang Jiang5, Yumei Xue2, Xianzhang Zhan2, Hongde Hu4, Guosheng Fu5, Kai Gu1, Hailei Liu1, Ligang Ding3, Ruhong Jiang5, Fa-Po Chung6, Yenn-Jiang Lin6, Yuichi Hori7, Yuki Komatsu8, Akiko Ueda9, Kyoko Soejima9, Young Hoon Kim10, Akihiko Nogami8, Shiro Nakahara7, Shih-Ann Chen6, Roderick Tung11. 1. Jiangsu Province Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China. 2. Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China. 3. Fuwai Cardiovascular Hospital, Beijing, China. 4. West China Hospital, Si Chuan University, Chengdu, China. 5. Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China. 6. School of Medicine, Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan. 7. Saitama Medical Center, Dokkyo Medical University, Mibu, Japan. 8. University of Tsukuba, Tsukuba, Japan. 9. Department of Cardiology, Kyorin University Hospital, Mitaka, Japan. 10. Korea University Anam Hospital, Seoul, South Korea. 11. Center for Arrhythmia Care, Pritzker School of Medicine, The University of Chicago Medicine, 5841 S. Maryland Ave. MC 6080, Chicago, IL, 60637, USA. rodericktung@uchicago.edu.
Abstract
BACKGROUND: The role of catheter ablation as an adjunct and alternative to ICD implantation is not known in patients at risk for recurrent ventricular tachycardia (VT) and sudden cardiac death (SCD) across Asia. Patients with nonischemic etiologies of cardiomyopathy, which are highly prevalent in Asia, have not been previously enrolled in randomized trials of VT ablation. OBJECTIVE: To evaluate whether preemptive catheter ablation in patients with monomorphic VT and an indication for ICD implantation results in improved clinical outcomes compared to ICD implantation with standard medical therapy alone. To examine the natural history of ablation outcomes in the absence of background ICD therapy in patients that refuse randomization. METHODS: The PAUSE-SCD study (NCT02848781) is a prospective, multi-center, randomized controlled trial enrolling patients with structural heart disease (EF < 50%) with an indication for ICD implantation. Patients are randomized in a 1:1 fashion to two treatment arms: ICD with ablation and ICD with standard medical therapy alone. A prospective registry cohort was designed to follow the outcomes of patients who refuse ICD and randomization but elect to receivecatheter ablation as primary therapy. The primary endpoint is defined as a composite of recurrent VT, cardiovascular rehospitalization, and death. Pre-specified secondary endpoints include each of the individual components of the primary endpoint in addition to comparison between randomized and registry patients. CONCLUSION: The PAUSE-SCD study is a prospective, multi-center, randomized, and controlled trial examining the impact of preemptive catheter ablation on cardiovascular outcomes in patients with an indication for ICD at risk for recurrent VT and SCD. It represents the first multi-center VT ablation study in Asia, with a design intended to provide insights into the role of both ICD and ablation therapy in a predominantly nonischemic population.
RCT Entities:
BACKGROUND: The role of catheter ablation as an adjunct and alternative to ICD implantation is not known in patients at risk for recurrent ventricular tachycardia (VT) and sudden cardiac death (SCD) across Asia. Patients with nonischemic etiologies of cardiomyopathy, which are highly prevalent in Asia, have not been previously enrolled in randomized trials of VT ablation. OBJECTIVE: To evaluate whether preemptive catheter ablation in patients with monomorphic VT and an indication for ICD implantation results in improved clinical outcomes compared to ICD implantation with standard medical therapy alone. To examine the natural history of ablation outcomes in the absence of background ICD therapy in patients that refuse randomization. METHODS: The PAUSE-SCD study (NCT02848781) is a prospective, multi-center, randomized controlled trial enrolling patients with structural heart disease (EF < 50%) with an indication for ICD implantation. Patients are randomized in a 1:1 fashion to two treatment arms: ICD with ablation and ICD with standard medical therapy alone. A prospective registry cohort was designed to follow the outcomes of patients who refuse ICD and randomization but elect to receive catheter ablation as primary therapy. The primary endpoint is defined as a composite of recurrent VT, cardiovascular rehospitalization, and death. Pre-specified secondary endpoints include each of the individual components of the primary endpoint in addition to comparison between randomized and registry patients. CONCLUSION: The PAUSE-SCD study is a prospective, multi-center, randomized, and controlled trial examining the impact of preemptive catheter ablation on cardiovascular outcomes in patients with an indication for ICD at risk for recurrent VT and SCD. It represents the first multi-center VT ablation study in Asia, with a design intended to provide insights into the role of both ICD and ablation therapy in a predominantly nonischemic population.
Entities:
Keywords:
Catheter ablation; ICD implantation; Sudden cardiac death
Authors: Tadanobu Irie; Ricky Yu; Jason S Bradfield; Marmar Vaseghi; Eric F Buch; Olujimi Ajijola; Carlos Macias; Osamu Fujimura; Ravi Mandapati; Noel G Boyle; Kalyanam Shivkumar; Roderick Tung Journal: Circ Arrhythm Electrophysiol Date: 2015-03-04
Authors: Luigi Di Biase; Pasquale Santangeli; David J Burkhardt; Rong Bai; Prasant Mohanty; Corrado Carbucicchio; Antonio Dello Russo; Michela Casella; Sanghamitra Mohanty; Agnes Pump; Richard Hongo; Salwa Beheiry; Gemma Pelargonio; Pietro Santarelli; Martina Zucchetti; Rodney Horton; Javier E Sanchez; Claude S Elayi; Dhanunjay Lakkireddy; Claudio Tondo; Andrea Natale Journal: J Am Coll Cardiol Date: 2012-07-10 Impact factor: 24.094
Authors: Yalçın Gökoğlan; Sanghamitra Mohanty; Carola Gianni; Pasquale Santangeli; Chintan Trivedi; Mahmut F Güneş; Rong Bai; Amin Al-Ahmad; G Joseph Gallinghouse; Rodney Horton; Patrick M Hranitzky; Javier E Sanchez; Salwa Beheiry; Richard Hongo; Dhanunjaya Lakkireddy; Madhu Reddy; Robert A Schweikert; Antonio Dello Russo; Michela Casella; Claudio Tondo; J David Burkhardt; Sakis Themistoclakis; Luigi Di Biase; Andrea Natale Journal: J Am Coll Cardiol Date: 2016-11-01 Impact factor: 24.094
Authors: Lars Køber; Jens J Thune; Jens C Nielsen; Jens Haarbo; Lars Videbæk; Eva Korup; Gunnar Jensen; Per Hildebrandt; Flemming H Steffensen; Niels E Bruun; Hans Eiskjær; Axel Brandes; Anna M Thøgersen; Finn Gustafsson; Kenneth Egstrup; Regitze Videbæk; Christian Hassager; Jesper H Svendsen; Dan E Høfsten; Christian Torp-Pedersen; Steen Pehrson Journal: N Engl J Med Date: 2016-08-27 Impact factor: 91.245
Authors: Vivek Y Reddy; Matthew R Reynolds; Petr Neuzil; Allison W Richardson; Milos Taborsky; Krit Jongnarangsin; Stepan Kralovec; Lucie Sediva; Jeremy N Ruskin; Mark E Josephson Journal: N Engl J Med Date: 2007-12-27 Impact factor: 91.245
Authors: Hildegard Tanner; Gerhard Hindricks; Marius Volkmer; Steve Furniss; Volker Kühlkamp; Dominique Lacroix; Christian DE Chillou; Jesús Almendral; Domenico Caponi; Karl-Heinz Kuck; Hans Kottkamp Journal: J Cardiovasc Electrophysiol Date: 2009-07-28
Authors: William G Stevenson; David J Wilber; Andrea Natale; Warren M Jackman; Francis E Marchlinski; Timothy Talbert; Mario D Gonzalez; Seth J Worley; Emile G Daoud; Chun Hwang; Claudio Schuger; Thomas E Bump; Mohammad Jazayeri; Gery F Tomassoni; Harry A Kopelman; Kyoko Soejima; Hiroshi Nakagawa Journal: Circulation Date: 2008-12-08 Impact factor: 29.690
Authors: Pierre Jaïs; Philippe Maury; Paul Khairy; Frédéric Sacher; Isabelle Nault; Yuki Komatsu; Mélèze Hocini; Andrei Forclaz; Amir S Jadidi; Rukshen Weerasooryia; Ashok Shah; Nicolas Derval; Hubert Cochet; Sebastien Knecht; Shinsuke Miyazaki; Nick Linton; Lena Rivard; Matthew Wright; Stephen B Wilton; Daniel Scherr; Patrizio Pascale; Laurent Roten; Michala Pederson; Pierre Bordachar; François Laurent; Steven J Kim; Philippe Ritter; Jacques Clementy; Michel Haïssaguerre Journal: Circulation Date: 2012-04-04 Impact factor: 29.690