title: Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials.
abstract: Catheter ablation of ventricular tachycardia (VT) has evolved in recent years, especially in patients with ischemic heart disease. Data from prospective studies show that VT catheter ablation reduces the risk of recurrent VT; however, there is a paucity of data on the effect of VT catheter ablation on mortality and patient-centered outcomes such as quality of life. Performing randomized clinical trials of VT catheter ablation can be fraught with challenges, and, as a result, several prior trials of VT catheter ablation had to be stopped prematurely. The main challenges are inability to blind the patient to therapy to obtain a traditional control group, high crossover rates between the 2 arms of the study, patient refusal to participate in trials in which they have an equal chance of receiving a "pill" vs an invasive procedure, heterogeneity of mapping and ablation techniques as well as catheters and equipment, rapid evolution of technology that may make findings of any long trial less relevant to clinical practice, lack of consensus on what constitutes acute procedural and long-term success, and presentation of patients to electrophysiologists late in the course of their disease. In this article, a panel of experts on VT catheter ablation and/or clinical trials of VT catheter ablation review challenges faced in conducting prior trials of VT catheter ablation and offer potential solutions for those challenges. It is hoped that the proposed solutions will enhance the feasibility of randomized clinical trials of VT catheter ablation.
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Sean D
authors.initials: SD
authors.lastname: Pokorney
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Friedman
authors.affiliation: The Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Hugh
authors.initials: H
authors.lastname: Calkins
authors.affiliation: University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: David J
authors.initials: DJ
authors.lastname: Callans
authors.affiliation: The Ohio State University, Columbus, Ohio.
authors.forename: Emile G
authors.initials: EG
authors.lastname: Daoud
authors.affiliation: Hospital San Raffaele, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Della-Bella
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Jackson
authors.affiliation: UCLA Health System, Los Angeles, California.
authors.forename: Kalyanam
authors.initials: K
authors.lastname: Shivkumar
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Samir
authors.initials: S
authors.lastname: Saba
authors.affiliation: QEII Health Sciences Centre, Halifax, NS, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Sapp
authors.affiliation: Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: William G
authors.initials: WG
authors.lastname: Stevenson
authors.affiliation: Duke University Medical Center, Durham, North Carolina. Electronic address: alkha001@mc.duke.edu.
authors.forename: Sana M
authors.initials: SM
authors.lastname: Al-Khatib
mesh_terms: D017115:Catheter Ablation / Q000379:methods*; D002986:Clinical Trials as Topic; D006801:Humans; D012008:Recurrence; D017180:Tachycardia, Ventricular / Q000503:physiopathology / Q000601:surgery*
keywords: Antitachycardia pacing; Appropriate shock; Catheter ablation; Clinical trials; Implantable cardioverter-defibrillator; Mortality; Ventricular tachycardia