Clinical trial NCT03624504: China Micra Transcatheter Pacing Study
Official title: China Micra Transcatheter Pacing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Keywords: Transcatheter Pacing System
Micra Implantable Device
Transfermoral Catheter Delivery System
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Subjects who are at least 18 years of age.

Exclusion Criteria:

1. Subject has an existing or prior pacemaker, ICD or CRT device implant.
2. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
3. 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.
4. Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
5. Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
6. 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.
7. Subjects who are considered as unable to tolerate an urgent sternotomy.
8. Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
9. Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
10. Subjects with a life expectancy of less than 12-months.
11. 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.
12. 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.
13. Subjects with exclusion criteria required by local law (age or other).
14. Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.

Primary outcomes:
measure: Percentage of Participants With Major Complications Free Survival Probability
timeFrame: 6 months post implant
Secondary outcomes:
measure: Pacing Capture Threshold (PCT)
timeFrame: Implant, Discharge, Month 1, Month 3, Month 6
measure: Impedance
timeFrame: Implant, Discharge, Month 1, Month 3, Month 6
measure: Sensing Amplitude
timeFrame: Implant, Discharge, Month 1, Month 3, Month 6
measure: Adverse Device Effect
timeFrame: From implant attempt to last subject follow-up, ranging from 0 to 14 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shu Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: