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China Micra Transcatheter Pacing Study

Primary Purpose

Bradycardia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Micra Transcatheter Pacing System (TPS)

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring Transcatheter Pacing System, Micra Implantable Device, Transfermoral Catheter Delivery System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fuwai Hospital Chinese Academy of Medical Sciences
Beijing Anzhen Hospital, Capital Medical University
Jiangsu Province Hospital
Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine
Zhongshan Hospital Fudan University
West China Hospital, Sichuan University
The Second Affliated Hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micra Implant Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pacing Capture Threshold (PCT)

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.

Impedance

Impedance measured from the Micra device Impedance is the opposition to current flow.

Sensing Amplitude

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.

Adverse Device Effect

Adverse event related to the Micra system or implant procedure

Full Information

NCT ID

NCT03624504

First Posted

July 13, 2018

Last Updated

September 9, 2020

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT03624504

Brief Title

China Micra Transcatheter Pacing Study

Official Title

China Micra Transcatheter Pacing Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

July 31, 2018 (Actual)

Primary Completion Date

August 29, 2019 (Actual)

Study Completion Date

January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bradycardia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Micra Implant Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Micra Transcatheter Pacing System (TPS)

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants With Major Complications Free Survival Probability

Description

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

Time Frame

6 months post implant

Secondary Outcome Measure Information:

Title

Pacing Capture Threshold (PCT)

Description

Time Frame

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

Title

Impedance

Description

Impedance measured from the Micra device Impedance is the opposition to current flow.

Time Frame

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

Title

Sensing Amplitude

Description

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.

Time Frame

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

Title

Adverse Device Effect

Description

Adverse event related to the Micra system or implant procedure

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shu Zhang, MD

Organizational Affiliation

Chinese Academy of Medical Sciences, Fuwai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Jiangsu Province Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200005

Country

China

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

West China Hospital, Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

The Second Affliated Hospital of Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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China Micra Transcatheter Pacing Study

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