Micra Study - to evaluate the safety and effectiveness of the Micra pacemaker and to assess its long-term performance.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/01/005445
• Date of registration: 22-01-2015
• Prospective Registration: Yes
• Primary sponsor: India Medtronic Pvt Ltd
• Public title: Micra Study - to evaluate the safety and effectiveness of the Micra pacemaker and to assess its long-term performance.
• Scientific title: MicraTM Transcatheter Pacing Study - MICRA
• Date of first enrolment: 18-02-2015
• Target sample size: 780
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8221
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 2/ Phase 3

Countries of recruitment

China, India, Japan, Malaysia, United States of America

Contacts

• Name: Haresh Sachanandani
• Affiliation: India Medtronic Pvt. Ltd.

• Name: Haresh Sachanandani
• Affiliation: India Medtronic Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: Subjects who have a Class I or II indication for implantation of a single chamber pacemaker

according to ACC/AHA/HRS 2008 guidelines and any national guidelines

• Subjects who are able and willing to undergo the study requirements

• Subjects who are geographically stable and are available for follow-up at the investigative site

through the duration of the study

• Subjects who are at least 18 years of age (or older, if required by local law)
Exclusion criteria: Subjects with current implantation of an implantable cardioverter defibrillator (ICD), implantable

pulse generator (IPG), cardiac resynchronization therapy (CRT), 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

• Patient with an expected life expectancy shorter than primary endpoint duration (i.e. 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. Co-enrollment in concurrent trials is only allowed

provided 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

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- 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.

Intervention(s)

Intervention1: MicraTM Implantable Device and Transfemoral Catheter Delivery System: The Micra Transcatheter Pacing System is a miniaturized (2g, 0.8cc) single chamber implantable
pacemaker that provides VVIR pacing therapy. The Micra device is fixed into the right ventricle via 4
nitinol tines, located on the distal end of the device. The implant procedure places the device through
a 23F transfemoral catheter delivery system. Additional system or accessory components include:
â?¢ Micra introducer sheath (accessory component)
â?¢ Micra software; downloaded on the standard Medtronic 2090 programmer (system component)
â?¢ Micra Holter (accessory component)
The implanted patient will be in teh study for 5 years depending on their enrollment
Control Intervention1: NO Comparator: NO Comparator

Primary Outcome(s)

Demonstrate that the freedom from acute major complications related the Micra technology at 30-

days post-implant is greater than 85%

â?¢ Demonstrate that the freedom from chronic major complications related to the Micra technology at

12-months is greater than 90%

â?¢ Demonstrate that the percentage of subjects with an adequate pacing capture threshold at 6-

months post-implant exceeds 80%.Timepoint: 1) 30 days Post Implant

2) 6 months Post Implant

Secondary Outcome(s)

Demonstrate the rate response operation of the Micra system.

â?¢ Demonstrate the accuracy of Micra ventricular capture management pacing thresholds compared

to manual pacing capture thresholds.Timepoint: 12 months

Secondary ID(s)

Version 2, 06 Jan 2014; G130245

Source(s) of Monetary Support

India Medtronic Pvt. Ltd.

Ethics review

Status: Approved
Approval date: 04/05/2014
Contact:

Institutional Ethics committee of CARE forundation

Status: Not Approved
Approval date:
Contact:

Institutional Ethics committee of AIIMS Hospital

Status: Not Approved
Approval date:
Contact:

Institutional Ethics committee of G.B. Pant Hospital