Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator

Michael S. Lloyd; Amy J. Brisben; Vivek Y. Reddy; Carina Blomström-Lundqvist; Lucas V.A. Boersma; Maria Grazia Bongiorni; Martin C. Burke; Daniel J. Cantillon; Rahul Doshi; Paul A. Friedman; Daniel Gras; Steven P. Kutalek; Petr Neuzil; Paul R. Roberts; David J. Wright; Ursula Appl; Julie West; Nathan Carter; Kenneth M. Stein; Lluis Mont; Reinoud E. Knops

doi:10.1016/j.hroo.2023.05.004

Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator

Michael S. Lloyd, Amy J. Brisben, Vivek Y. Reddy, Carina Blomström-Lundqvist, Lucas V.A. Boersma, Maria Grazia Bongiorni, Martin C. Burke, Daniel J. Cantillon, Rahul Doshi, Paul A. Friedman, Daniel Gras, Steven P. Kutalek, Petr Neuzil, Paul R. Roberts, David J. Wright, Ursula Appl, Julie West, Nathan Carter, Kenneth M. Stein, Lluis MontReinoud E. Knops

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support. Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented. Methods: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years. Results: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described. Conclusion: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.

Original language	English (US)
Pages (from-to)	448-456
Number of pages	9
Journal	Heart Rhythm O2
Volume	4
Issue number	7
DOIs	https://doi.org/10.1016/j.hroo.2023.05.004
State	Published - Jul 2023

Keywords

Antitachycardia pacing
Defibrillator
Leadless pacemaker
Subcutaneous ICD
Transcatheter pacemaker

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.hroo.2023.05.004

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Lloyd, M. S., Brisben, A. J., Reddy, V. Y., Blomström-Lundqvist, C., Boersma, L. V. A., Bongiorni, M. G., Burke, M. C., Cantillon, D. J., Doshi, R., Friedman, P. A., Gras, D., Kutalek, S. P., Neuzil, P., Roberts, P. R., Wright, D. J., Appl, U., West, J., Carter, N., Stein, K. M., ... Knops, R. E. (2023). Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm O2, 4(7), 448-456. https://doi.org/10.1016/j.hroo.2023.05.004

Lloyd, MS, Brisben, AJ, Reddy, VY, Blomström-Lundqvist, C, Boersma, LVA, Bongiorni, MG, Burke, MC, Cantillon, DJ, Doshi, R, Friedman, PA, Gras, D, Kutalek, SP, Neuzil, P, Roberts, PR, Wright, DJ, Appl, U, West, J, Carter, N, Stein, KM, Mont, L & Knops, RE 2023, 'Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator', Heart Rhythm O2, vol. 4, no. 7, pp. 448-456. https://doi.org/10.1016/j.hroo.2023.05.004

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title = "Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator",

abstract = "Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support. Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented. Methods: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER{\texttrademark} Modular Pacing System and EMBLEM{\texttrademark} Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years. Results: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described. Conclusion: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.",

keywords = "Antitachycardia pacing, Defibrillator, Leadless pacemaker, Subcutaneous ICD, Transcatheter pacemaker",

author = "Lloyd, {Michael S.} and Brisben, {Amy J.} and Reddy, {Vivek Y.} and Carina Blomstr{\"o}m-Lundqvist and Boersma, {Lucas V.A.} and Bongiorni, {Maria Grazia} and Burke, {Martin C.} and Cantillon, {Daniel J.} and Rahul Doshi and Friedman, {Paul A.} and Daniel Gras and Kutalek, {Steven P.} and Petr Neuzil and Roberts, {Paul R.} and Wright, {David J.} and Ursula Appl and Julie West and Nathan Carter and Stein, {Kenneth M.} and Lluis Mont and Knops, {Reinoud E.}",

note = "Publisher Copyright: {\textcopyright} 2023 Heart Rhythm Society",

year = "2023",

month = jul,

doi = "10.1016/j.hroo.2023.05.004",

language = "English (US)",

volume = "4",

pages = "448--456",

journal = "Heart Rhythm O2",

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publisher = "Elsevier Inc.",

number = "7",

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TY - JOUR

T1 - Design and rationale of the MODULAR ATP global clinical trial

T2 - A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator

AU - Lloyd, Michael S.

AU - Brisben, Amy J.

AU - Reddy, Vivek Y.

AU - Blomström-Lundqvist, Carina

AU - Boersma, Lucas V.A.

AU - Bongiorni, Maria Grazia

AU - Burke, Martin C.

AU - Cantillon, Daniel J.

AU - Doshi, Rahul

AU - Friedman, Paul A.

AU - Gras, Daniel

AU - Kutalek, Steven P.

AU - Neuzil, Petr

AU - Roberts, Paul R.

AU - Wright, David J.

AU - Appl, Ursula

AU - West, Julie

AU - Carter, Nathan

AU - Stein, Kenneth M.

AU - Mont, Lluis

AU - Knops, Reinoud E.

PY - 2023/7

Y1 - 2023/7

N2 - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support. Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented. Methods: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years. Results: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described. Conclusion: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.

AB - Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support. Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented. Methods: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years. Results: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described. Conclusion: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.

KW - Antitachycardia pacing

KW - Defibrillator

KW - Leadless pacemaker

KW - Subcutaneous ICD

KW - Transcatheter pacemaker

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Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator

Abstract

Keywords

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