China Micra Transcatheter Pacing Study

NCT03624504 | Completed Results FDA Device

• 1 other identifier: China Micra
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 7

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.

Conditions

Bradycardia

Keywords

Transcatheter Pacing System; Micra Implantable Device; Transfermoral Catheter Delivery System

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Major Complications Free Survival Probability

  Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant

  6 months post implant

Secondary Outcomes (4)

• Pacing Capture Threshold (PCT)

  Implant, Discharge, Month 1, Month 3, Month 6

• Impedance

  Implant, Discharge, Month 1, Month 3, Month 6

• Sensing Amplitude

  Implant, Discharge, Month 1, Month 3, Month 6

• Adverse Device Effect

  From implant attempt to last subject follow-up, ranging from 0 to 14 months

Study Arms (1)

Micra Implant Group

EXPERIMENTAL

Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS)

Device: Micra Transcatheter Pacing System (TPS)

Interventions

Micra Transcatheter Pacing System (TPS) DEVICE

Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements

Micra Implant Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 medical condition which precludes patient from participation in the opinion of the Investigator.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (7)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200005, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Second Affliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Weifan Sun, Clinical Study Manager
• Organization: Medtronic (Shanghai) Management Co., Ltd.

weifan.sun@medtronic.com

021-20325267

Study Officials

• Shu Zhang, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 10, 2018
• Study Start: July 31, 2018
• Primary Completion: August 29, 2019
• Study Completion: January 20, 2020
• Last Updated: September 30, 2020
• Results First Posted: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)