Indications for VVI(R) PacemakerNCT02051972

The LEADLESS Observational Study

An observational study of Indications for VVI(R) Pacemaker, run by Abbott Medical Devices at 32 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Indications for VVI(R) Pacemaker
What is being tested?: Implanted with a Nanostim leadless pacemaker system
Type of treatment: Medical device
How many people: 491 participants
Where: 32 sitesin 7 countries
Study dates: Dec 2013to 22 Dec 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

32 sites in 7 countries.

Country

City, postcode or hospital

32 sites in 7 countries

Germany9 sites

Kerckhoff-Klinik gGmbH
Bad Nauheim, 61231
Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200
Klinikum Bielefeld gGmbH Klinikum-Mitte
Bielefeld, 33604
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 01307
Asklepios Klinik St. Georg
Hamburg, 20099
Kath. Krankenhaus Marienhospital
Herne, 44625
Herzzentrum Leipzig GmbH
Leipzig, 04289
Deutsches Herzzentrum München des Freistaates Bayern
München, 80636
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, 78052

Other trials in Germany

Italy6 sites

Az. Osp. Spedali Civili di Brescia
Brescia, 25124
Ospedale San Raffaele
Milan, 20132
Ospedale Niguarda Ca'Granda
Milan, 20132
Centro Cardiologico Monzino
Milan, 20138
Policlinico San Donato
San Donato Milanese, 20097
Azienda Ospedaliera Bolognini
Seriate, 24068

Other trials in Italy

France5 sites

CHRU Albert Michallon
Grenoble, 38043
Hopital La Timone
Marseille, 13385
Nouvelles cliniques Nantaises
Nantes, 44270
CHRU Hopital de Pontchaillou
Rennes, 35033
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200

Other trials in France

Spain5 sites

Hospital Infanta Cristina
Badajoz, 6080
Hospital Universitario de la Paz
Madrid, 28046
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Donostia
San Sebastián, 20014
Hospital do Meixoeiro
Vigo, 36214

Other trials in Spain

United Kingdom4 sites

St. Bartholomew's Hospital
London, EC1A 7BE
Royal Brompton Hospital
London, SW3 6NP
Manchester Heart Center, Manchester Royal Infirmary
Manchester, M13 9WL
John Radcliffe Hospital
Oxford, OX3 9DU

Other trials in United Kingdom

Netherlands2 sites

AMC
Amsterdam, 1105 AZ
Isala Klinieken
Zwolle, 8025

Other trials in Netherlands

Czechia1 site

Na Homolce Hospital
Prague, 150 30

Other trials in Czechia

About this study

Official title: 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.

Conditions: Indications for VVI(R) Pacemaker
Being tested: Implanted with a Nanostim leadless pacemaker system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implanted with a Nanostim leadless pacemaker systemDevice

Study groups in NCT02051972
Study group	Role	What they receive
Indicated for a VVI(R) pacemaker		Not described Receives: Device: Implanted with a Nanostim leadless pacemaker system

What is being measured

The primary outcome is the main question the study is designed to answer.

Complication Free-rate
A complication is defined as a serious adverse device effect
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201322 Dec 2021

First posted31 Jan 2014 (estimated)
Study startDec 2013
Primary completionMar 2017
Study completion22 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Indications for VVI(R) PacemakerStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 491 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02051972
Sponsor's protocol ID: LCP005
Status last verified: May 2025
First submitted: 30 Jan 2014
Last updated: 6 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 27932427

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nanostim Study for a Leadless Cardiac Pacemaker System
ClinicalTrials.gov ID: NCT02051972
Acronym / sponsor ID: LCP005
Conditions: Indications for VVI(R) Pacemaker
Study type: Observational
Recruitment status: Completed
Enrolment: 491 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Dec 2013 (actual)
Primary completion: Mar 2017 (actual)
Study completion: 22 Dec 2021 (actual)
First posted: 31 Jan 2014 (estimated)
Results: Posted 6 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Indicated for a VVI(R) pacemaker	–	Device: Implanted with a Nanostim leadless pacemaker system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects who are at least 18 years old and who are indicated for a VVI(R) pacemaker

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Implanted with a Nanostim leadless pacemaker system	Device	Indicated for a VVI(R) pacemaker

Primary outcome

Complication Free-rate
Time frame: 6 months
A complication is defined as a serious adverse device effect

Results and safety

Results posted to the registry on 6 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indicated for a VVI(R) Pacemaker	488	139

Primary outcome: Complication Free-rate

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Indicated for a VVI(R) Pacemaker n = 300
Number of patients with SADEs	16
Number of patients free of SADEs	284

Population analysed: The evaluation was completed for the first 300 subjects that completed 6 months of follow-up.

Adverse events

Time frame: The adverse event were collected over a period of 8 years. Other adverse events reported at 0.2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indicated for a VVI(R) Pacemaker	142 of 491 (28.9%)	7 of 491 (1.4%)	140 of 491

Limitations and caveats (from the sponsor): The primary safety endpoint was met however, the supplementary endpoint of freedom from complications at 5 years was only evaluated using descriptive analyses. The enrollment goal for a powered analysis was not met since enrollments were suspended on October 28, 2016. The Nanostim LP device was not commercialized in the US and commercial sales in the EU were discontinued in 2016. The device was redesigned into the Aveir VR LP device- evaluated in the LEADLESS II Phase 2 study (NCT04559945.)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27932427Reddy 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johannes Sperzel, MD principal investigator

Kerckhoff Klinick GmbH, Bad Nauheim, Germany

32 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Indications for VVI(R) Pacemaker, run by Abbott Medical Devices at 32 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Germany, Italy, France, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complication Free-rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02051972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.