Evidence map›Paper›PMID 41231774›Full record

Trial reportCirculation. Arrhythmia and electrophysiology2026

One-Year Outcomes of the MODULAR ATP Trial: A Novel Leadless Pacemaker in Wireless Communication With a Subcutaneous Implantable Cardioverter Defibrillator.

Michael S Lloyd, Vivek Y Reddy, Paul Roberts, Rahul N Doshi, David L Wright, Lucas V A Boersma, Paul A Friedman, Petr Neuzil, Carina Blomström-Lundqvist, Maria Grazia Bongiorni and 16 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Circulation. Arrhythmia and electrophysiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04798768 (Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04798768 naactive not recruitingnot on this map

Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing

TypeinterventionalSponsorBoston Scientific CorporationRan2021 to 2030Enrolled297ConditionsTachycardia, Ventricular, Arrhythmia, VentricularArmsmCRM Therapy System
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Michael S LloydSection of Cardiac Electrophysiology, Emory University, Atlanta, GA (M.S.L.).ORCID 0000-0002-0708-9330
Vivek Y ReddyCardiac Electrophysiology, Mount Sinai Fuster Heart Hospital, New York, NY (V.Y.R.).ORCID 0000-0002-5638-4993
Paul RobertsClinical Cardiology Research, University Hospital Southampton, United Kingdom (P.R.).ORCID 0000-0002-1174-6401
Rahul N DoshiCardiac Arrhythmia Group and HonorHealth Research Institute, Honor Health, Scottsdale, AZ (R.N.D.).ORCID 0000-0001-5555-7672
David L WrightDepartment of Cardiology, Liverpool Heart and Chest Hospital, United Kingdom (D.L.W.).ORCID 0000-0002-5783-6648
Lucas V A BoersmaDepartment of Cardiology, St Antonius Hospital, Nieuwegein, Utrecht, the Netherlands (L.V.A.B.).ORCID 0000-0003-4591-4220
Paul A FriedmanDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (P.A.F.).ORCID 0000-0001-5052-2948
Petr NeuzilDepartment of Cardiology, Na Homolce Hospital, Prague, Czechia (P.N.).ORCID 0000-0003-4334-8165
Carina Blomström-LundqvistDepartment of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örsebro & Uppsala University, Sweden (C.B.-L.).ORCID 0000-0003-2806-3903
Maria Grazia BongiorniHeart Rhythm Clinic, San Rossore Private Hospital, Pisa, Italy (M.G.B.).ORCID 0009-0002-4755-1064
Martin C BurkeCorVita Science Foundation, Chicago, IL (M.C.B.).ORCID 0000-0003-0522-6466
Daniel GrasDepartement de Cardiologie, Hôpital Privé du Confluent, Nantes, France (D.G.).ORCID 0000-0002-7980-6036
Steven P KutalekCardiac Electrophysiology, Drexel University College of Medicine, Philadelphia (S.P.K.).ORCID 0000-0001-5643-0569
Eloi MarijonDepartment of Cardiology, Division of Cardiology, European Georges-Pompidou Hospital, Paris, France (E. Marijon).ORCID 0000-0001-7227-3428
Jose María TolosanaInstitut Clínic Cardiovascular, Hospital Clínic, Universitat de Barcelona, Spain (J.M.T., L.M.).ORCID 0000-0002-1215-3472
Anish K AminSection of Cardiac Electrophysiology, Department of Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, Ohio (A.K.A.).ORCID 0000-0001-6432-1573
Laurence M EpsteinCardiac Electrophysiology, Northwell Health, Manhasset, NY (L.M.E.).ORCID 0000-0001-5410-0291
Johan D AasboLexington Cardiology/Baptist Health Lexington, KY (J.D.A.).ORCID 0000-0002-3572-1567
Thomas D CallahanCardiac Electrophysiology and Pacing Section, Department of Cardiovascular Medicine, Cleveland Clinic, EP, OH (T.D.C.).ORCID 0000-0001-5281-7598
Amy J BrisbenCardiac Rhythm Management, Boston Scientific, St Paul, MN (A.J.B., J.W., E. Matznick, B.S., T.N.B.).ORCID 0000-0002-6519-3320
Julie WestCardiac Rhythm Management, Boston Scientific, St Paul, MN (A.J.B., J.W., E. Matznick, B.S., T.N.B.).
Elizabeth MatznickCardiac Rhythm Management, Boston Scientific, St Paul, MN (A.J.B., J.W., E. Matznick, B.S., T.N.B.).ORCID 0000-0002-4608-4284
Benjamin SpeakmanCardiac Rhythm Management, Boston Scientific, St Paul, MN (A.J.B., J.W., E. Matznick, B.S., T.N.B.).
Tara N BachmanCardiac Rhythm Management, Boston Scientific, St Paul, MN (A.J.B., J.W., E. Matznick, B.S., T.N.B.).ORCID 0009-0005-9246-253X
Lluís MontInstitut Clínic Cardiovascular, Hospital Clínic, Universitat de Barcelona, Spain (J.M.T., L.M.).ORCID 0000-0002-8115-5906
Reinoud E KnopsDepartment of Cardiology, Amsterdam UMC, the Netherlands (L.V.A.B., R.E.K.).ORCID 0000-0002-0772-3573

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMODULAR antitachycardia pacing (ATP), a multicenter, international trial, assesses a modular cardiac rhythm management system: a subcutaneous implantable cardioverter defibrillator in wireless communication with a leadless pacemaker (LP) capable of pace-terminating ventricular tachycardia.

methodsEnrolees had one or more clinical risk factors for ventricular tachycardia and did not require chronic pacing. Complications included prespecified major LP system- and procedure-related complications, and any complication related to the LP, subcutaneous implantable cardioverter defibrillator, implantation, or study protocol. Survival analysis was performed to identify complication-free rates, therapy delivery, and all-cause mortality.

resultsThe 297 patients enrolled had an ejection fraction of 35±13%, 43% secondary prevention indications, and 59% with prior ventricular arrhythmias. Of 286 patients undergoing LP implantation (100% success), 251 patients completed 12-month follow-up. Mortality rate was 6%, with none related to the implant procedure. Median follow-up duration was 23.4 months (interquartile range, 17.9-28.1). The LP major complication-free rate was 97.2%, exceeding the performance goal. The overall LP+ subcutaneous implantable cardioverter defibrillator system-related complication-free rate was 88.5%. Appropriate tachyarrhythmia-therapy (ATP+shock) rates were 14.4%, and appropriate shock rates were 8.5%. Inappropriate total tachyarrhythmia therapy was 9.5% of which 8.5% were shocks. ATP was 67.3% successful in terminating ventricular arrhythmia episodes and accelerated ventricular arrhythmias in 10.1% of episodes. Overall therapy burden (ATP+shock) was 96/100 patient-years, of which 44/100 patient-years was for shock delivery.

conclusionsOne-year outcomes of the first modular pacing-defibrillator system reveal low system and LP complication rates and good ATP efficacy rates, suggesting that the modular cardiac rhythm management is a viable alternative to single-chamber implantable cardioverter defibrillators using low-energy pacing capability without the need for transvenous leads. CLINICAL

trial registrationURL: https://clinicaltrials.gov/; Unique identifier: NCT04798768.

Indexed as

Cardiac Pacing, ArtificialDefibrillators, ImplantableElectric CountershockHeart RatePacemaker, ArtificialTachycardia, VentricularWireless TechnologyAgedAged, 80 and overEquipment DesignFemaleHumansMaleMiddle AgedRisk FactorsTime Factorsbradycardiatachycardia defibrillators

Identifiers

PMID41231774
PMCPMC12822781

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.