Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F23%3A00009666" target="_blank" >RIV/00023884:_____/23:00009666 - isvavai.cz</a>
Result on the web
<a href="https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/pii/S2666501823001290" target="_blank" >https://www-sciencedirect-com.ezproxy.lib.cas.cz/science/article/pii/S2666501823001290</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.hroo.2023.05.004" target="_blank" >10.1016/j.hroo.2023.05.004</a>
Alternative languages
Result language
angličtina
Original language name
Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator
Original language description
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 (TM) Modular Pacing System and EMBLEM (TM) Subcutaneous ICD to Communicate Antitachycardia Pacing) is amulticenter, 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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Heart Rhythm O2
ISSN
2666-5018
e-ISSN
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Volume of the periodical
4
Issue of the periodical within the volume
7
Country of publishing house
US - UNITED STATES
Number of pages
9
Pages from-to
448-456
UT code for WoS article
001050060900001
EID of the result in the Scopus database
2-s2.0-85163863591