The LEADLESS Observational Study

May 19, 2025 updated by: Abbott Medical Devices

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
491

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Hopital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Indicated for a VVI(R) pacemaker
Device: Implanted with a Nanostim leadless pacemaker system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complication Free-rate
Time Frame: 6 months
A complication is defined as a serious adverse device effect
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long Term Freedom From Complications
Time Frame: 5 years
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
Time Frame: 90 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Johannes Sperzel, MD, Kerckhoff Klinick GmbH, Bad Nauheim, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCP005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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