The LEADLESS Observational Study

Completed

• Conditions: Indications for VVI(R) Pacemaker
• Interventions: Device: Implanted with a Nanostim leadless pacemaker system

• Registration Number: NCT02051972
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Primary Completion: 2017-03
• Study Completion: 2021-12-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indicated for a VVI(R) pacemaker	Implanted with a Nanostim leadless pacemaker system	-

Primary Outcome Measures

Name	Time	Method
Complication free-rate	6 months	A complication is defined as a serious adverse device effect

Trial Locations

Locations (32)

Az. Osp. Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

AMC; 🇳🇱 Amsterdam, Netherlands

Na Homolce Hospital; 🇨🇿 Prague, Czechia

CHRU Albert Michallon; 🇫🇷 Grenoble, France

Hopital La Timone; 🇫🇷 Marseille, France

Nouvelles cliniques Nantaises; 🇫🇷 Nantes, France

CHU Strasbourg - Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

CHRU Hopital de Pontchaillou; 🇫🇷 Rennes, 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

Kath. Krankenhaus Marienhospital; 🇩🇪 Herne, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Kliniken Villingen-Schwenningen; 🇩🇪 Villingen-Schwenningen, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Deutsches Herzzentrum München des Freistaates Bayern; 🇩🇪 München, Germany

Centro Cardiologico Monzino; 🇮🇹 Milano, Italy

Ospedale Niguarda Ca'Granda; 🇮🇹 Milano, Italy

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

Ospedale San Raffaele; 🇮🇹 Milan, Italy

Azienda Ospedaliera Bolognini; 🇮🇹 Seriate, Italy

Hospital Infanta Cristina; 🇪🇸 Badajoz, Spain

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

Hospital Universitario de la Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Donostia; 🇪🇸 San Sebastián, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Hospital do Meixoeiro; 🇪🇸 Vigo, Spain

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom

Manchester Heart Center, Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom