The LEADLESS Observational Study

NCT ID: NCT02051972

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 491 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2021-12-22

Brief Summary

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.

Conditions

Indications for VVI(R) Pacemaker

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Indicated for a VVI(R) pacemaker

Implanted with a Nanostim leadless pacemaker system

Intervention Type: DEVICE

Interventions

Implanted with a Nanostim leadless pacemaker system

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Sperzel, MD

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Klinick GmbH, Bad Nauheim, Germany

Locations

Na Homolce Hospital

Prague, , Czechia

CHRU Albert Michallon

Grenoble, , France

Hopital La Timone

Marseille, , France

Nouvelles cliniques Nantaises

Nantes, , France

CHRU Hopital de Pontchaillou

Rennes, , France

CHU Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Kerckhoff-Klinik gGmbH

Bad Nauheim, , Germany

Universitätsmedizin Berlin - Campus Benjamin Franklin

Berlin, , Germany

Klinikum Bielefeld gGmbH Klinikum-Mitte

Bielefeld, , Germany

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Kath. Krankenhaus Marienhospital

Herne, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Deutsches Herzzentrum München des Freistaates Bayern

München, , Germany

Kliniken Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Az. Osp. Spedali Civili di Brescia

Brescia, , Italy

Ospedale San Raffaele

Milan, , Italy

Ospedale Niguarda Ca'Granda

Milan, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Policlinico San Donato

San Donato Milanese, , Italy

Azienda Ospedaliera Bolognini

Seriate, , Italy

AMC

Amsterdam, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Hospital Infanta Cristina

Badajoz, , Spain

Hospital Universitario de la Paz

Madrid, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Donostia

San Sebastián, , Spain

Hospital do Meixoeiro

Vigo, , Spain

St. Bartholomew's Hospital

London, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

Manchester Heart Center, Manchester Royal Infirmary

Manchester, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Countries

Czechia; France; Germany; Italy; Netherlands; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27932427 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LCP005

Identifier Type: -

Identifier Source: org_study_id