The LEADLESS Observational Study

Nanostim Study for a Leadless Cardiac Pacemaker System

The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.

Study Overview

• Status: Completed
• Conditions: Indications for VVI(R) Pacemaker
• Intervention / Treatment: Device: Implanted with a Nanostim leadless pacemaker system

• Study Type: Observational
• Enrollment (Actual): 491

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital
• France
  • Grenoble, France, 38043
    • CHRU Albert Michallon
  • Marseille, France, 13385
    • Hôpital La Timone
  • Nantes, France, 44270
    • Nouvelles Cliniques Nantaises
  • Rennes, France, 35033
    • CHRU Hôpital de Pontchaillou
  • Strasbourg, France, 67200
    • Chu Strasbourg - Hôpital de Hautepierre
• Germany
  • Bad nauheim, Germany, 61231
    • Kerckhoff-Klinik gGmbH
  • Berlin, Germany, 12200
    • Universitätsmedizin Berlin - Campus Benjamin Franklin
  • Bielefeld, Germany, 33604
    • Klinikum Bielefeld gGmbH Klinikum-Mitte
  • Dresden, Germany, 01307
    • Herzzentrum Dresden GmbH Universitätsklinik
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Herne, Germany, 44625
    • Kath. Krankenhaus Marienhospital
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • München, Germany, 80636
    • Deutsches Herzzentrum München des Freistaates Bayern
  • Villingen-Schwenningen, Germany, 78052
    • Kliniken Villingen-Schwenningen
• Italy
  • Brescia, Italy, 25124
    • Az. Osp. Spedali Civili di Brescia
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milano, Italy, 20138
    • Centro Cardiologico Monzino
  • Milano, Italy, 20132
    • Ospedale Niguarda Ca'Granda
  • San Donato Milanese, Italy, 20097
    • Policlinico San Donato
  • Seriate, Italy, 24068
    • Azienda Ospedaliera Bolognini
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • AMC
  • Zwolle, Netherlands, 8025
    • Isala Klinieken
• Spain
  • Badajoz, Spain, 6080
    • Hospital Infanta Cristina
  • Madrid, Spain, 28046
    • Hospital Universitario de La Paz
  • Salamanca, Spain, 37007
    • Hospital Universitario De Salamanca
  • San Sebastián, Spain, 20014
    • Hospital Universitario Donostia
  • Vigo, Spain, 36214
    • Hospital Do Meixoeiro
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • St. Bartholomew's Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Manchester, United Kingdom, M13 9WL
    • Manchester Heart Center, Manchester Royal Infirmary
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are at least 18 years old and who are indicated for a VVI(R) pacemaker

Description

Inclusion Criteria:

• Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or Normal sinus rhythm with 2º or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
• Subject ≥18 years of age; and
• Subject has life expectancy of at least one year and is a suitable candidate based on overall health and well-being; and
• Subject is not enrolled in another clinical investigation with a treatment arm or that could confound the results of this study; and
• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
• Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; and
• Subject is not pregnant and does not plan on getting pregnant during the course of the study.

Exclusion Criteria:

• Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or
• Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; or
• Mechanical tricuspid valve prosthesis; or
• Pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40mmHg) or significant physiologically-impairing lung disease (has severe pulmonary disease producing frequent hospitalization for respiratory distress or requiring continuous home oxygen); or
• Pre-existing ventricular pacing or defibrillation leads; or
• Current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
• Presence of implanted vena cava filter; or
• Evidence of thrombosis in one of the veins used for access during the procedure; or
• Cardiovascular or peripheral vascular surgery/intervention within 30 days of enrolment; or
• Presence of implanted leadless cardiac pacemaker

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Indicated for a VVI(R) pacemaker	Device: Implanted with a Nanostim leadless pacemaker system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Free-rate	A complication is defined as a serious adverse device effect	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Freedom From Complications	A complication is defined as a serious adverse device effect. The complication-free rate was calculated using the Kaplan-Meier method, and the 95% confidence interval was estimated using the Greenwood method.	5 years
Long Term Freedom From Complications	A complication is defined as a serious adverse device effect. The complication-free rate was calculated using the Kaplan-Meier method, and the 95% confidence interval was estimated using the Greenwood method.	90 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Johannes Sperzel, MD, Kerckhoff Klinick GmbH, Bad Nauheim, Germany

Publications and helpful links

General Publications

• Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimated): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: LCP005