The Rhythm ID Going Head to Head Trial (RIGHT): Design of a Randomized Trial Comparing Competitive Rhythm Discrimination Algorithms in Implantable Cardioverter Defibrillators

Background: The implantable cardioverter defibrillator (ICD) has become primary therapy for the prevention of sudden death. One of the major morbidities of ICD use remains inappropriate therapy for supraventricular arrhythmias (SVA). Detection enhancements have increased therapy specificity, but their impact on inappropriate therapy is not well studied. Moreover, ICD manufacturers have developed unique algorithms to meet this goal, with no previous clinical direct comparisons. RIGHT is a randomized, prospective study that will assess the differential efficacy of ICDs from two different manufacturers. It is the first trial to compare directly competitive ICD rhythm discrimination algorithms on a large scale.

[1]  O. Pachinger,et al.  Inappropriate Detection of Supraventricular Arrhythmias by Implantable Dual Chamber Defibrillators: A Comparison of Four Different Algorithms , 2001, Pacing and clinical electrophysiology : PACE.

[2]  K. Nanthakumar,et al.  Is Inappropriate Implantable Defibrillator Shock Therapy Predictable? , 2003, Journal of Interventional Cardiac Electrophysiology.

[3]  M. Walters,et al.  Pulmonary Embolization of a Pacing Electrode Fragment Complicating Lead Extraction , 1999, Pacing and clinical electrophysiology : PACE.

[4]  M. Schlepper,et al.  Programmable VT Detection Enhancements in Implantable Cardioverter Defibrillator Therapy , 1995, Pacing and clinical electrophysiology : PACE.

[5]  K. Ellenbogen,et al.  Critical Analysis of Dual-Chamber Implantable Cardioverter-Defibrillator Arrhythmia Detection: Results and Technical Considerations , 2001, Circulation.

[6]  S. Pinski,et al.  The proarrhythmic potential of implantable cardioverter-defibrillators. , 1995, Circulation.

[7]  R. Stroobandt Morphology Discrimination of Ventricular Tachycardia from Supraventricular Tachycardia by Implantable Cardioverter Defibrillators: Are Implantable Cardioverter Defibrillators Really Starting to Look at Arrhythmias with the Eyes of a Cardiologist? , 2002, Journal of cardiovascular electrophysiology.

[8]  R. Cappato,et al.  Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). , 2000, Circulation.

[9]  M. Rosenqvist,et al.  Adverse events with transvenous implantable cardioverter-defibrillators: a prospective multicenter study. European 7219 Jewel ICD investigators. , 1998, Circulation.

[10]  M Gent,et al.  Canadian implantable defibrillator study (CIDS) : a randomized trial of the implantable cardioverter defibrillator against amiodarone. , 2000, Circulation.

[11]  W. Grimm,et al.  Complications of Third‐Generation Implantable Cardioverter Defibrillator Therapy , 1999, Pacing and clinical electrophysiology : PACE.

[12]  H. Wellens,et al.  Dual Chamber Arrhythmia Detection in the Implantable Cardioverter Defibrillator , 2000, Journal of cardiovascular electrophysiology.

[13]  E. Gang,et al.  Underdetection of ventricular tachycardia by algorithms to enhance specificity in a tiered-therapy cardioverter-defibrillator. , 1994, Journal of the American College of Cardiology.

[14]  A. Vinet,et al.  Underdetection of Ventricular Tachycardia Using a 40 ms Stability Criterion: Effect of Antiarrhythmic Therapy , 1997, Pacing and clinical electrophysiology : PACE.

[15]  J. Ruskin,et al.  Limitations and late complications of third-generation automatic cardioverter-defibrillators. , 1995, Circulation.

[16]  Angelo Branzi,et al.  Combined Use of Morphology Discrimination, Sudden Onset, and Stability as Discriminating Algorithms in Single Chamber Cardioverter Defibrillators , 2002, Pacing and clinical electrophysiology : PACE.

[17]  M. Giudici,et al.  Clinical Results of an Advanced SVT Detection Enhancement Algorithm , 2005, Pacing and clinical electrophysiology : PACE.

[18]  G. Boriani,et al.  Rhythm Discrimination by Rate Branch and QRS Morphology in Dual Chamber Implantable Cardioverter Defibrillators , 2003, Pacing and clinical electrophysiology : PACE.

[19]  Alain Ripart,et al.  Arrhythmia detection by dual-chamber implantable cardioverter defibrillators. A review of current algorithms. , 2004, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[20]  V. Kühlkamp,et al.  Clinical Experience with the New Detection Algorithms for Atrial Fibrillation of a Defibrillator with Dual Chamber Sensing and Pacing , 1999, Journal of cardiovascular electrophysiology.

[21]  J. Brugada,et al.  Enhanced Detection Criteria in Implantable Defibrillators , 1998, Journal of cardiovascular electrophysiology.

[22]  S. Hsu,et al.  T Wave Oversensing in Implantable Cardioverter Defibrillators , 2004, Journal of Interventional Cardiac Electrophysiology.

[23]  K. K. Lan,et al.  Discrete sequential boundaries for clinical trials , 1983 .

[24]  Walter H Olson,et al.  Discrimination of Ventricular Tachycardia from Supraventricular Tachycardia by a Downloaded Wavelet‐Transform Morphology Algorithm: A Paradigm for Development of Implantable Cardioverter Defibrillator Detection Algorithms , 2002, Journal of cardiovascular electrophysiology.

[25]  M. Gold,et al.  Advanced Rhythm Discrimination for Implantable Cardioverter Defibrillators Using Electrogram Vector Timing and Correlation , 2002, Journal of cardiovascular electrophysiology.

[26]  J. Windle,et al.  Quality‐of‐Life Six Months After CABG Surgery in Patients Randomized to ICD Versus No ICD Therapy: Findings from the CABG Patch Trial , 1999, Pacing and clinical electrophysiology : PACE.

[27]  N. Sheth,et al.  Detection of atrial fibrillation and flutter by a dual-chamber implantable cardioverter-defibrillator. For the Worldwide Jewel AF Investigators. , 2000, Circulation.