- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624504
China Micra Transcatheter Pacing Study
September 9, 2020 updated by: Medtronic Cardiac Rhythm and Heart Failure
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for regulatory approval in China.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All study sites will be in China.
Subjects successfully implanted with the Micra system in all sites will be followed at implant/pre-discharge, 1-month, 3-months, and 6-months, and at 6-month intervals thereafter (if applicable) through study closure.
The overall follow-up period of the study will end when the last enrolled patient has 6 months of follow-up.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Fuwai Hospital Chinese Academy of Medical Sciences
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Beijing, Beijing, China
- Beijing Anzhen Hospital, Capital Medical University
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital
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-
Shanghai
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Shanghai, Shanghai, China, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Shanghai, China, 200005
- Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- The Second Affliated Hospital of Zhejiang University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 China guideline.
- Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
- Subjects who are at least 18 years of age.
Exclusion Criteria:
- 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 (12.5 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. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.
- Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.
- Subjects with exclusion criteria required by local law (age or other).
- Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Micra Implant Group
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS)
|
Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Major Complications Free Survival Probability
Time Frame: 6 months post implant
|
Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant
|
6 months post implant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pacing Capture Threshold (PCT)
Time Frame: Implant, Discharge, Month 1, Month 3, Month 6
|
Pacing capture threshold @0.24ms pulse width Capture threshold is defined as the minimum electrical stimulus required to consistently capture the heart outside of the myocardial refractory period. Pulse width is the duration of the current flow expressed in milliseconds. The pulse width must be long enough for depolarization to disperse to the surrounding tissue. |
Implant, Discharge, Month 1, Month 3, Month 6
|
Impedance
Time Frame: Implant, Discharge, Month 1, Month 3, Month 6
|
Impedance measured from the Micra device Impedance is the opposition to current flow.
|
Implant, Discharge, Month 1, Month 3, Month 6
|
Sensing Amplitude
Time Frame: Implant, Discharge, Month 1, Month 3, Month 6
|
R-wave sensing amplitude measured from the Micra device Sensing is the ability of the pacemaker to "see" when a natural (intrinsic) depolarization is occurring.
|
Implant, Discharge, Month 1, Month 3, Month 6
|
Adverse Device Effect
Time Frame: From implant attempt to last subject follow-up, ranging from 0 to 14 months
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Adverse event related to the Micra system or implant procedure
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From implant attempt to last subject follow-up, ranging from 0 to 14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shu Zhang, MD, Chinese Academy of Medical Sciences, Fuwai Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2018
Primary Completion (Actual)
August 29, 2019
Study Completion (Actual)
January 20, 2020
Study Registration Dates
First Submitted
July 13, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 10, 2018
Study Record Updates
Last Update Posted (Actual)
September 30, 2020
Last Update Submitted That Met QC Criteria
September 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- China Micra
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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