Micra Transcatheter Pacing Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT02004873
First received: December 3, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Device: Micra Pacemaker Implant
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Micra Transcatheter Pacing Study

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Major Complications [ Time Frame: Implant to 6 Months Post Implant ] [ Designated as safety issue: No ]
    Micra system and/or procedure related major complication free rate 6-months post-implant

  • Pacing Capture Threshold Success [ Time Frame: 6-Months Post Implant ] [ Designated as safety issue: No ]
    Pacing capture threshold (PCT) at the 6-month post-implant visit where success is defined as PCT <=2 volts at 0.24 ms pulse width and the increase from implant is <=1.5 volts.


Secondary Outcome Measures:
  • Micra Ventricular Capture Management (VCMT) [ Time Frame: 6-Months Post Implant ] [ Designated as safety issue: No ]
    Percentage of subjects that have a VCMT that is within 0.5 Volts of the manual (auto decrement) PCT (0.24 ms pulse width) at the 6-month post-implant visit

  • Rate Response [ Time Frame: 3-Months and 6-Months Post Implant ] [ Designated as safety issue: No ]
    The Micra sensor-indicated rate derived from the input of the accelerometer during the M-PREP treadmill test at the 3-month and 6-month follow-up visits


Estimated Enrollment: 780
Study Start Date: November 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Micra Pacemaker Implant Device: Micra Pacemaker Implant

Detailed Description:

The study is expected to be conducted in up to 70 sites located around the world, including up to 35 sites in the United States (U.S.).Participating geographies may include countries such as the U.S, Europe, China, India, Malaysia, and Japan.

Up to 780 subjects will 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 will be evaluated at 6-months (183 days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, will also 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  • 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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004873

Contacts
Contact: Micra Study Manager 800-328-2518 rs.micra@medtronic.com

  Show 26 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Dwight Reynolds University of Oklahoma
Study Chair: Philippe Ritter Hôpital Haut-Lévêque
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT02004873     History of Changes
Other Study ID Numbers: Micra
Study First Received: December 3, 2013
Last Updated: February 19, 2014
Health Authority: Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care
China: Ethics Committee
China: China Food and Drug Administration Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Ethics Committee
Hungary: Scientific and Medical Research Council Ethics Committee
Hungary : Competent Authority: EEKH Orvostechnikai Főosztály - Office of Health Authorisation and Administrative Procedures, Department of Medical Devices
India: Central Drugs Standard Control Organization
India: Drugs Controller General of India
India: Indian Council of Medical Research
India: Institutional Review Board
India: Ministry of Health & Welfare
India: State Drug Control Authorities
Italy: Ethics Committee
Italy: Ministry of Health
Japan: Institutional Review Board
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Malaysia: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Russia: The Ministry of Education and Science of the Russian Federation
Serbia: Ethics Committee
Serbia: Medicines and Medical Devices Agency
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
pacemaker
leadless
single chamber

ClinicalTrials.gov processed this record on September 16, 2014