Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jun 2;4(7):448-456.
doi: 10.1016/j.hroo.2023.05.004. eCollection 2023 Jul.

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  1 , Amy J Brisben  2 , Vivek Y Reddy  3 , Carina Blomström-Lundqvist  4   5 , Lucas V A Boersma  6   7 , Maria Grazia Bongiorni  8 , Martin C Burke  9 , Daniel J Cantillon  10 , Rahul Doshi  11   12 , Paul A Friedman  13 , Daniel Gras  14 , Steven P Kutalek  15   16 , Petr Neuzil  17 , Paul R Roberts  18 , David J Wright  19 , Ursula Appl  2 , Julie West  2 , Nathan Carter  2 , Kenneth M Stein  2 , Lluis Mont  20   21 , Reinoud E Knops  7
Affiliations

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 et al. Heart Rhythm O2. .

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.

Keywords: Antitachycardia pacing; Defibrillator; Leadless pacemaker; Subcutaneous ICD; Transcatheter pacemaker.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Modular cardiac rhythm management (mCRM) therapy system. A: The mCRM therapy system: leadless pacemaker and subcutaneous implantable cardioverter-defibrillator pulse generators. B: Illustration of the implanted mCRM therapy system.
Figure 2
Figure 2
Study overview. mCRM = modular cardiac rhythm management; S-ICD = subcutaneous implantable cardioverter-defibrillator.
Figure 3
Figure 3
Endpoint analysis. Temporal and conditional map of endpoints, designed to minimize type I errors. S-ICD = subcutaneous implantable cardioverter-defibrillator; PG = pulse generator.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Knops R.E., Olde Nordkamp L.R.A., Delnoy P.H.M., et al. Subcutaneous or transvenous defibrillator therapy. N Engl J Med. 2020;383:526–536. - PubMed
    1. Healey J.S., Krahn A.D., Bashir J., et al. Perioperative safety and early patient and device outcomes among subcutaneous versus transvenous implantable cardioverter defibrillator implantations: a randomized, multicenter trial. Ann Intern Med. 2022;175:1658–1665. - PubMed
    1. Weiss R., Knight B.P., Gold M.R., et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128:944–953. - PubMed
    1. Lambiase P.D., Theuns D.A., Murgatroyd F., et al. Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study. Eur Heart J. 2022;43:2037–2050. - PMC - PubMed
    1. Gold M.R., Lambiase P.D., El-Chami M.F., et al. Primary results from the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) trial. Circulation. 2021;143:7–17. - PMC - PubMed