Micra Transcatheter Pacing Study

Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines Clinical Trial

Official title:

Micra Transcatheter Pacing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004873
• Other study ID #: Micra
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: December 18, 2017
• Start date: November 2013
• Est. completion date: May 2017

Study information

• Verified date: December 2017
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

Description:

The study is being conducted in 56 sites located around the world, including 30 sites in the United States (U.S.).

Up to 780 subjects were planned to be enrolled (i.e. consented) to allow up to 720 subjects to be implanted enabling at least 600 subjects to be followed for at least 12-months post-implant.

There are two primary objectives in this study (one safety and one efficacy). The primary safety objective of the study is to evaluate major complications related to the Micra system or procedure. The primary safety endpoint was pre-specified to be evaluated at 6-months (183 days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, was also pre-specified to be evaluated six months post-implant. This study also has a separate long term safety objective that will provide additional long-term safety data following potential regulatory submissions.

All subjects will be followed until official study closure (official study closure is defined as when Medtronic and/or FDA requirements have been satisfied per the Clinical Investigational Plan and/or by a decision by Medtronic or regulatory authority).

Additionally, the Micra Accelerometer Sensor Sub-Study (MASS) is being conducted at 4 centers already active in the Micra study in Austria, Spain, Hungary and France. Forty (40) subjects were enrolled in the Sub-Study, and enrollment in the Sub-Study was complete as of March 31, 2016. The purpose of the Sub-Study is to test feasibility for future enhancements in the Micra device functionalities.

An algorithm was designed to sense the atrial contraction using the Micra accelerometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: May 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and any national guidelines

• Subjects who are able and willing to undergo the study requirements and are expected to be geographically stable for the duration of the follow-up.

• Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion Criteria:

• Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm). (Please note:

Subjects who are entirely pacemaker dependent (escape rhythm <30 bpm) can now be included in the study. Medtronic notified all sites on July 23, 2014 that the restriction against pacemaker dependent subjects was lifted, following review of the Early Performance Assessment.)

• Subject has an existing or prior pacemaker, ICD or CRT device implant.

• Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.

• Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.

• Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).

• Subjects who are morbidly obese and physician believes telemetry communication of =5 inches (12.7 cm) could not be obtained with programmer head.

• Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.

• Subjects who are considered as unable to tolerate an urgent sternotomy

• Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.

• Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.

• Subjects with a life expectancy of less than 12- months.

• Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Coenrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.

• Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.

• Subjects with exclusion criteria required by local law (e.g. age, breast feeding, etc.).

Related Conditions & MeSH terms

• Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Intervention

Device:
• Micra Pacemaker Implant

Locations

Country	Name	City	State
Australia	Princess Alexandria Hospital	Woolloongabba	Queensland
Austria	Allgemeines Krankenhaus der Stadt Linz	Linz
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Quebec
China	Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing
Czechia	Nemocnice Na Homolce	Praha
Denmark	Rigshospitalet	København
France	Hôpital Haut-Lévêque - CHU de Bordeaux	Bordeaux
Greece	University General Hospital of Heraklion	Heraklion
Hungary	Magyar Honvédség Honvédkorház	Budapest
India	CARE Hospitals	Hyderabad
India	All India Institute of Medical Sciences	New Delhi
India	Govind Ballabh Pant Hospital	New Delhi
Italy	Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara	Pisa
Japan	National Cerebral and Cardiovascular Center	Osaka
Japan	Showa University Hospital	Shinagawa-Ku
Japan	Kyorin University Hospital	Tokyo
Japan	Yokohama City University Hospital	Yokohama
Malaysia	Institut Jantung Negara - National Heart Institute	Kuala Lumpur
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	St. Antonius Ziekenhuis - Locatie Nieuwegein	Nieuwegein
Serbia	Klinicki Centar Srbije	Belgrade
South Africa	Groote Schuur Hospital	Cape Town
Spain	Hospital Universitari Clínic de Barcelona	Barcelona
United Kingdom	Southampton General Hospital - University Hospital Southampton NHS Foundation Trust	Southampton
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	The Stern Cardiovascular Clinic	Germantown	Tennessee
United States	St. Luke's Medical Center	Houston	Texas
United States	Baptist Heart Specialists	Jacksonville	Florida
United States	Mid America Heart Institute	Kansas City	Missouri
United States	Scripps	La Jolla	California
United States	Lancaster Heart & Vascular Research Institute	Lancaster	Pennsylvania
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	North Shore LIJ Health System	Manhasset	New York
United States	Baptist Hospital of Miami	Miami	Florida
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	NYU Langone Medical Center	New York	New York
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Science Center (OUHSC)	Oklahoma City	Oklahoma
United States	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Providence Health & Services	Portland	Oregon
United States	The Valley Hospital	Ridgewood	New Jersey
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  China,  Czechia,  Denmark,  France,  Greece,  Hungary,  India,  Italy,  Japan,  Malaysia,  Netherlands,  Serbia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Complications	Micra system and/or procedure related major complication free rate at 6-months post-implant.	Implant to 6 Months Post Implant
Primary	Pacing Capture Threshold	Subjects that have an adequate pacing capture threshold (PCT) at the 6-month post-implant visit, which is defined as PCT <=2 volts at 0.24 ms pulse width and the increase in PCT from implant to 6 months <=1.5 volts. The pacing capture threshold is the minimal electrical stimulus required to produce consistent cardiac depolarization. It is the minimum amount of energy that is required for a pacemaker to pace the heart.	6 Months Post Implant
Secondary	Ventricular Capture Management Threshold	Subjects that have a ventricular capture management threshold (VCMT) that is within 0.5 Volts of the manual (auto decrement) PCT (at 0.24 ms pulse width) at the 6-month post-implant visit. The VCMT is an automatically measured pacing capture threshold that is measured by the Micra device's pacing algorithm. In contrast, the manual (auto decrement) pacing capture threshold is measured by the clinician during a study visit.	6 Months Post Implant
Secondary	Rate Response Operation of Micra	Assessment of whether the Micra sensor-indicated rate derived from the input of the accelerometer during the Minnesota Pacemaker Response Exercise Protocol (M-PREP) treadmill test conducted at the 3-month and 6-month follow-up visits was proportional to the workload. The sensor-indicated rate (in min^-1) and workload (in METS) were normalized for each subject relative to their minimum and maximum possible values so the normalized values have a minimum possible value of zero and a maximum possible value of 1. These normalized values were used in a random effect linear regression model to assess the relationship between the sensor-indicated rate and workload via estimation of the Kay-Wilkoff slope parameter. The tests at 3-month and 6-month visits were combined in one analysis.	3 Months and 6 Months Post Implant (combined analysis)