Clinical trial NCT02536118: Micra Transcatheter Pacing System Post-Approval Registry
Official title: Micra Transcatheter Pacing System Post-Approval Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bradycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2015-08-31
Enrollment: 3100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intended to be implanted with a Micra system are eligible for enrollment and all patients must be consented prior to the implant. Only geographies with regulatory approval for the Micra system are eligible to enroll patients (see locations section).

All patients enrolled and successfully implanted with a Micra system will be followed for a minimum of 9 years, unless a patient is exited from the registry due to an unavoidable reason. If a Micra system is not successfully implanted, patients will be exited from the registry unless a Micra System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.

Brief summary: Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.

The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

Detailed description: The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry\*.

Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.

\*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.

Eligibility criteria: Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Primary outcomes:
measure: Acute complication rate
timeFrame: 30-days
measure: Long-term complication free survival
timeFrame: 9 years
Secondary outcomes:
measure: Pacing impedance (ohms) and pacing threshold (volts)
timeFrame: Up to 9 years
measure: Complications stratified by implant type
timeFrame: Up to 9 years
measure: Estimate Micra System revision rate
timeFrame: Up to 9 years
measure: Estimate System Longevity
timeFrame: Up to 9 years
measure: Confirm the rate response operation of the Micra system
timeFrame: Approximately 2 years
Other outcomes:
measure: Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment
timeFrame: Up to 9 years
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Redwood City
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: West Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Edgewood
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Saint Cloud
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Morristown
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: Huntington
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
city: Brussel
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Kingston
country: Canada
state: Ontario
city: Montréal
country: Canada
city: Praha
country: Czechia
city: Arhus
country: Denmark
city: Hillerød
country: Denmark
city: Kobenhavn
country: Denmark
city: Odense
country: Denmark
city: Annecy
country: France
city: Bayonne
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Chambray les tours
country: France
city: Clermont Ferrand Cedex
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Neuilly Sur Seine
country: France
city: Rennes Cedex 9
country: France
city: Rouen
country: France
city: Saint Etienne
country: France
city: Saint-Denis
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Villeurbanne
country: France
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Dusseldorf
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Köln
country: Germany
city: Mainz
country: Germany
city: Munster
country: Germany
city: Tübingen
country: Germany
city: Ulm
country: Germany
city: Athens
country: Greece
city: Marousi
country: Greece
city: Budapest
country: Hungary
city: Reykjavík
country: Iceland
city: Ashqelon
country: Israel
city: Jerusalem
country: Israel
city: Ramat-Gan
country: Israel
city: Bari
country: Italy
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Cotignola
country: Italy
city: Milano
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Mitaka-shi
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Suita
country: Japan
city: Yokohama
country: Japan
city: Safat
country: Kuwait
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Den Haag
country: Netherlands
city: Eindhoven
country: Netherlands
city: Enschede
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Christchurch
country: New Zealand
city: Bergen
country: Norway
city: Trondheim
country: Norway
city: Poznan
country: Poland
city: Zabrze
country: Poland
city: Lisboa
country: Portugal
city: Jeddah
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
city: Barcelona
country: Spain
city: Coruña
country: Spain
city: Santiago de Compostela
country: Spain
city: Toledo
country: Spain
city: Vitoria-Gasteiz
country: Spain
city: Uppsala
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Fribourg
country: Switzerland
city: Geneve
country: Switzerland
city: Lausanne
country: Switzerland
city: Lugano
country: Switzerland
city: Zurich
country: Switzerland
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Medtronic
name: Micra Registry Manager
role: STUDY_DIRECTOR
References:
citation: Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.
citation: El-Chami MF, Garweg C, Iacopino S, Al-Samadi F, Martinez-Sande JL, Tondo C, Johansen JB, Prat XV, Piccini JP, Cha YM, Grubman E, Bordachar P, Roberts PR, Soejima K, Stromberg K, Fagan DH, Clementy N. Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2022 Feb;19(2):228-234. doi: 10.1016/j.hrthm.2021.10.023. Epub 2021 Oct 29.
citation: El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.
citation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.
citation: El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Vinolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.