BACKGROUND: The magnitude of benefit of cardiac resynchronization therapy (CRT) varies significantly among its recipients; approximately 30% of CRT patients do not report clinical improvement. Optimization of CRT pacing parameters can further improve cardiac function, both acutely and chronically. Echocardiographic optimization is used in clinical practice, but it is time and resource consuming. In addition, optimal settings at rest may change later with activity or cardiac remodeling. The adaptive CRT (aCRT) algorithm was designed to provide automatic ambulatory adjustment of CRT pacing configuration (left ventricular or biventricular pacing) and device delays based on periodic measurement of electrical conduction intervals. METHODS: The aCRT algorithm is currently undergoing evaluation in a prospective, randomized, double-blinded, worldwide clinical trial. The trial enrolled 522 patients, who satisfied standard clinical indications for a CRT device. Within 2 weeks after the implant, the patients were randomized to aCRT versus echo-optimized biventricular pacing (Echo) settings in 2:1 ratio and followed up at 1-, 3-, 6-, and 12-month postrandomization. The noninferiority primary trial objectives at 6-month postrandomization are to demonstrate that (a) the percentage of aCRT patients who improved in their clinical composite score is at least as high as the percentage of Echo patients; (b) cardiac performance as assessed by echocardiography is similar when using aCRT settings versus echo-optimized settings; and (c) aCRT does not result in inappropriate device settings. First and last patient enrollments occurred in November 2009 and December 2010, respectively. CONCLUSIONS: The safety and efficacy of the aCRT algorithm will be evaluated in this ongoing clinical trial.
RCT Entities:
BACKGROUND: The magnitude of benefit of cardiac resynchronization therapy (CRT) varies significantly among its recipients; approximately 30% of CRT patients do not report clinical improvement. Optimization of CRT pacing parameters can further improve cardiac function, both acutely and chronically. Echocardiographic optimization is used in clinical practice, but it is time and resource consuming. In addition, optimal settings at rest may change later with activity or cardiac remodeling. The adaptive CRT (aCRT) algorithm was designed to provide automatic ambulatory adjustment of CRT pacing configuration (left ventricular or biventricular pacing) and device delays based on periodic measurement of electrical conduction intervals. METHODS: The aCRT algorithm is currently undergoing evaluation in a prospective, randomized, double-blinded, worldwide clinical trial. The trial enrolled 522 patients, who satisfied standard clinical indications for a CRT device. Within 2 weeks after the implant, the patients were randomized to aCRT versus echo-optimized biventricular pacing (Echo) settings in 2:1 ratio and followed up at 1-, 3-, 6-, and 12-month postrandomization. The noninferiority primary trial objectives at 6-month postrandomization are to demonstrate that (a) the percentage of aCRT patients who improved in their clinical composite score is at least as high as the percentage of Echo patients; (b) cardiac performance as assessed by echocardiography is similar when using aCRT settings versus echo-optimized settings; and (c) aCRT does not result in inappropriate device settings. First and last patient enrollments occurred in November 2009 and December 2010, respectively. CONCLUSIONS: The safety and efficacy of the aCRT algorithm will be evaluated in this ongoing clinical trial.
Authors: Kazi T Haq; Nichole M Rogovoy; Jason A Thomas; Christopher Hamilton; Katherine J Lutz; Ashley Wirth; Aron B Bender; David M German; Ryle Przybylowicz; Peter van Dam; Thomas A Dewland; Khidir Dalouk; Eric Stecker; Babak Nazer; Peter M Jessel; Karen S MacMurdy; Ignatius Gerardo E Zarraga; Bassel Beitinjaneh; Charles A Henrikson; Merritt Raitt; Cristina Fuss; Maros Ferencik; Larisa G Tereshchenko Journal: Heart Rhythm O2 Date: 2021-06-29
Authors: Philippe André; Benoit Plourde; Franck Molin; Jean-Francois Sarrazin; Jean Champagne; François Philippon Journal: HeartRhythm Case Rep Date: 2018-06-05
Authors: Ahmed AlTurki; Pedro Y Lima; Martin L Bernier; Daniel Garcia; Alejandro Vidal; Bruno Toscani; Sergio Diaz; Mauricio Montemezzo; Alaa Al-Dossari; Tomy Hadjis; Jacqueline Joza; Vidal Essebag Journal: CJC Open Date: 2020-01-21
Authors: Bruce L Wilkoff; David Birnie; Michael R Gold; Ahmad S Hersi; Sandra Jacobs; Bart Gerritse; Kengo Kusano; Christophe Leclercq; Wilfried Mullens; Gerasimos Filippatos Journal: ESC Heart Fail Date: 2020-08-13