Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker

The New England Journal of Medicine
Vivek Y ReddyLEADLESS II Study Investigators

Abstract

Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully self-contained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter. In this multicenter study, we implanted an active-fixation leadless cardiac pacemaker in patients who required permanent single-chamber ventricular pacing. The primary efficacy end point was both an acceptable pacing threshold (≤2.0 V at 0.4 msec) and an acceptable sensing amplitude (R wave ≥5.0 mV, or a value equal to or greater than the value at implantation) through 6 months. The primary safety end point was freedom from device-related serious adverse events through 6 months. In this ongoing study, the prespecified analysis of the primary end points was performed on data from the first 300 patients who completed 6 months of follow-up (primary cohort). The rates of the efficacy end point and safety end point were compared with performance goals (based on historical data) of 85% and 86%, respectively. Additional outcomes were assessed in all 526 patients who were enrolled as of June 2015 (the total cohort). The leadless pacemaker was successfully implanted in...Continue Reading

Associated Clinical Trials

References

Jun 14, 2002·The New England Journal of Medicine·Gervasio A LamasUNKNOWN Mode Selection Trial in Sinus-Node Dysfunction
Sep 21, 2005·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Srijoy MahapatraDavid L Hayes
Feb 6, 2007·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Robert G HauserMarleen Irwin
Mar 7, 2007·Pacing and Clinical Electrophysiology : PACE·Petri KorkeilaK E Juhani Airaksinen
Mar 21, 2007·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Majid HaghjooMohammad Ali Sadr-Ameli
Oct 12, 2010·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Bruce L WilkoffUNKNOWN EnRhythm MRI SureScan Pacing System Study Investigators
Dec 21, 2011·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Erik O UdoKarel G M Moons
Jan 28, 2012·Journal of the American Society of Echocardiography : Official Publication of the American Society of Echocardiography·Maha A Al-Mohaissen, Kwan Leung Chan
Feb 15, 2013·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Pietro PalmisanoStefano Favale
Mar 26, 2014·Circulation·Vivek Y ReddyPetr Neuzil
Dec 4, 2014·Pacing and Clinical Electrophysiology : PACE·Moshe Rav AchaTheofanie Mela
Dec 30, 2014·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Sylvain PlouxPierre Bordachar
Apr 18, 2015·Journal of the American College of Cardiology·Reinoud E KnopsVivek Y Reddy

❮ Previous
Next ❯

Citations

Jan 5, 2016·European Heart Journal·Jan SteffelGerhard Hindricks
Feb 11, 2016·The New England Journal of Medicine·Vivek Y Reddy
Nov 10, 2015·The New England Journal of Medicine·Mark S Link
Nov 10, 2015·The New England Journal of Medicine·Dwight ReynoldsUNKNOWN Micra Transcatheter Pacing Study Group
Jan 5, 2016·Nature Reviews. Cardiology·Laurent Macle, Stanley Nattel
Nov 4, 2016·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·F V Y TjongR E Knops
Oct 16, 2015·Circulation Journal : Official Journal of the Japanese Circulation Society·Tsuyoshi Nishiguchi, Takashi Akasaka
Apr 14, 2016·Trends in Cardiovascular Medicine·Christopher Aldo Rinaldi
Mar 17, 2016·MMW Fortschritte der Medizin·Brigitte OsswaldAlexander Siebel
Mar 26, 2016·Journal of the American College of Cardiology·Fleur V Y TjongReinoud E Knops
Oct 16, 2015·Current Treatment Options in Cardiovascular Medicine·Ian Lindsay, Jeremy P Moore
Mar 28, 2016·Trends in Cardiovascular Medicine·Christopher Austin, Fred Kusumoto
Apr 15, 2016·Expert Review of Medical Devices·Volkmar Falk, Christoph T Starck
Feb 24, 2016·Heart Views : the Official Journal of the Gulf Heart Association·Hajar A Albinali
May 6, 2016·Current Cardiology Reports·Steven Leung, Stephan Danik
Jun 10, 2016·Cardiology and Therapy·Claire McCuneIan B A Menown
Jun 12, 2016·Current Treatment Options in Cardiovascular Medicine·Hans Rutzen-LopezRobert H Helm
Jul 28, 2016·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Thomas R KamburRajiv Agarwal
Jun 15, 2016·Journal of Cardiovascular Electrophysiology·Alexander KyptaClemens Steinwender
Jun 30, 2016·The New England Journal of Medicine·Dwight W Reynolds, Philippe Ritter
Sep 28, 2016·Indian Pacing and Electrophysiology Journal·Arun Gopi
Sep 1, 2016·Scandinavian Cardiovascular Journal : SCJ·Marcus StåhlbergCecilia Linde
Mar 2, 2016·Anesthesiology Clinics·Ana Costa, Deborah C Richman
Oct 27, 2016·Journal of Cardiovascular Electrophysiology·Paul A FriedmanEric N Prystowsky
Nov 2, 2016·Future Cardiology·Michele MalagùMatteo Bertini
May 26, 2016·Pacing and Clinical Electrophysiology : PACE·Chu-Pak Lau, Kathy Lai-Fun Lee
Nov 23, 2016·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Michael LloydGabor Z Duray
Dec 3, 2016·Revista Española De Cardiología·María Luisa Fidalgo AndrésJulia Martín Fernández
Dec 8, 2016·Journal of Cardiovascular Electrophysiology·Mate VamosStefan H Hohnloser
Nov 9, 2016·Scientific Reports·Fabrice MarquetBruno Quesson
Mar 16, 2017·Pacing and Clinical Electrophysiology : PACE·Jahangir Rashid BeigHilal A Rather
Mar 2, 2017·Journal of Cardiovascular Electrophysiology·Antonio Raviele, Antonio Rossillo
May 11, 2017·Expert Review of Cardiovascular Therapy·Kristin EllisonRichard Trohman
May 16, 2017·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Paul R RobertsMikhael F El-Chami
Jun 25, 2017·Hellenic Journal of Cardiology : HJC = Hellēnikē Kardiologikē Epitheōrēsē·Skevos SiderisDimitrios Tousoulis
Jun 9, 2017·Pacing and Clinical Electrophysiology : PACE·Jodie Franzil, Jason Rytlewski
Mar 15, 2018·Journal of Cardiovascular Medicine·Riccardo Cappato
Mar 20, 2018·The Journal of Vascular Access·Mariusz Kusztal, Krzysztof Nowak
Feb 25, 2018·Pacing and Clinical Electrophysiology : PACE·Toshimasa OkabeJohn D Hummel
Oct 25, 2017·Journal of Thoracic Imaging·Anupama G Brixey, Cristina Fuss
May 13, 2017·Journal of Atrial Fibrillation·Pawel MatusikRemigiusz Noworolski
Sep 22, 2017·Seminars in Cardiothoracic and Vascular Anesthesia·Meena BhatiaJames M Anton
Dec 19, 2017·Journal of Atrial Fibrillation·Krishna KancharlaPaul A Friedman
Aug 1, 2018·Future Cardiology·Cameron T LambertKhaldoun G Tarakji
Aug 2, 2018·Pacing and Clinical Electrophysiology : PACE·Yan WangHai-Jun Zhang

❮ Previous
Next ❯

Related Concepts

Related Feeds

Atrial Fibrillation

Atrial fibrillation is a common arrhythmia that is associated with substantial morbidity and mortality, particularly due to stroke and thromboembolism. Here is the latest research.

Arrhythmia

Arrhythmias are abnormalities in heart rhythms, which can be either too fast or too slow. They can result from abnormalities of the initiation of an impulse or impulse conduction or a combination of both. Here is the latest research on arrhythmias.