Clinical trial NCT02051972: The LEADLESS Observational Study
Official title: Nanostim Study for a Leadless Cardiac Pacemaker System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Indications for VVI(R) Pacemaker
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are at least 18 years old and who are indicated for a VVI(R) pacemaker

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.


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

Primary outcomes:
measure: Complication Free-rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Long Term Freedom From Complications
timeFrame: 5 years
measure: Long Term Freedom From Complications
timeFrame: 90 days
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Grenoble
country: France
facility: CHRU Albert Michallon
city: Marseille
country: France
facility: Hopital La Timone
city: Nantes
country: France
facility: Nouvelles cliniques Nantaises
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Strasbourg
country: France
facility: CHU Strasbourg - Hôpital de Hautepierre
city: Bad nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Campus Benjamin Franklin
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld gGmbH Klinikum-Mitte
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Herne
country: Germany
facility: Kath. Krankenhaus Marienhospital
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen-Schwenningen
city: Brescia
country: Italy
facility: Az. Osp. Spedali Civili di Brescia
city: Milano
country: Italy
facility: Ospedale Niguarda Ca'Granda
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Seriate
country: Italy
facility: Azienda Ospedaliera Bolognini
city: Amsterdam
country: Netherlands
facility: AMC
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Manchester Heart Center, Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Kerckhoff Klinick GmbH, Bad Nauheim, Germany
name: Johannes Sperzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.