Trial Outcomes & Findings for China Micra Transcatheter Pacing Study (NCT NCT03624504)
NCT ID: NCT03624504
Last Updated: 2020-09-30
Results Overview
Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
6 months post implant
Results posted on
2020-09-30
Participant Flow
Participant milestones
| Measure |
Micra Implant Group
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Micra Implant Group
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Overall Study
Unsuccessful Implant
|
1
|
Baseline Characteristics
China Micra Transcatheter Pacing Study
Baseline characteristics by cohort
| Measure |
Micra Implant Group
n=82 Participants
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS)
Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Age, Continuous
|
68.50 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethinic Chinese
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
82 Participants
n=5 Participants
|
|
BMI
|
24.0 kg/m^2
STANDARD_DEVIATION 3.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post implantFreedom rate from Micra implant procedure and/or system related major complications through 6 months post implant
Outcome measures
| Measure |
Micra Implant Group
n=82 Participants
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Percentage of Participants With Major Complications Free Survival Probability
|
97.6 percentage of participants
Interval 90.6 to 99.4
|
SECONDARY outcome
Timeframe: Implant, Discharge, Month 1, Month 3, Month 6Population: 81 subjects with successful implant were eligible at follow up for this data. One subject at Month 1 did not have the PCT completed, so the data is not summarized below.
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.
Outcome measures
| Measure |
Micra Implant Group
n=81 Participants
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Pacing Capture Threshold (PCT)
Implant
|
0.52 Volts
Standard Deviation 0.29
|
|
Pacing Capture Threshold (PCT)
Discharge
|
0.52 Volts
Standard Deviation 0.43
|
|
Pacing Capture Threshold (PCT)
1 Month
|
0.50 Volts
Standard Deviation 0.57
|
|
Pacing Capture Threshold (PCT)
3 Months
|
0.47 Volts
Standard Deviation 0.30
|
|
Pacing Capture Threshold (PCT)
6 Months
|
0.50 Volts
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Implant, Discharge, Month 1, Month 3, Month 6Population: 81 subject with successful implant
Impedance measured from the Micra device Impedance is the opposition to current flow.
Outcome measures
| Measure |
Micra Implant Group
n=81 Participants
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Impedance
Implant
|
873.83 Ohms
Standard Deviation 228.26
|
|
Impedance
Discharge
|
781.73 Ohms
Standard Deviation 193.85
|
|
Impedance
1 Month
|
719.38 Ohms
Standard Deviation 142.27
|
|
Impedance
3 Months
|
659.01 Ohms
Standard Deviation 130.04
|
|
Impedance
6 Months
|
632.22 Ohms
Standard Deviation 124.68
|
SECONDARY outcome
Timeframe: Implant, Discharge, Month 1, Month 3, Month 6Population: 81 subjects with successful implant were eligible at follow up for this data. One subject at Month 1 did not have the R-wave sensing amplitude completed, so the data is not summarized below.
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.
Outcome measures
| Measure |
Micra Implant Group
n=81 Participants
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Sensing Amplitude
Implant
|
9.41 mV
Standard Deviation 3.87
|
|
Sensing Amplitude
Discharge
|
11.16 mV
Standard Deviation 3.88
|
|
Sensing Amplitude
1 Month
|
13.53 mV
Standard Deviation 3.65
|
|
Sensing Amplitude
3 Months
|
13.78 mV
Standard Deviation 4.05
|
|
Sensing Amplitude
6 Months
|
13.87 mV
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: From implant attempt to last subject follow-up, ranging from 0 to 14 monthsPopulation: All enrolled patients with an implant attempt
Adverse event related to the Micra system or implant procedure
Outcome measures
| Measure |
Micra Implant Group
n=82 Participants
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Adverse Device Effect
Anaemia
|
1 Participants
|
|
Adverse Device Effect
Arteriovenous fistula
|
1 Participants
|
|
Adverse Device Effect
Bundle branch block right
|
3 Participants
|
|
Adverse Device Effect
Chest pain
|
1 Participants
|
|
Adverse Device Effect
Deep vein thrombosis
|
1 Participants
|
|
Adverse Device Effect
Device pacing issue
|
1 Participants
|
|
Adverse Device Effect
Dizziness
|
1 Participants
|
|
Adverse Device Effect
Myocardial necrosis marker increased
|
1 Participants
|
|
Adverse Device Effect
Oedema peripheral
|
1 Participants
|
|
Adverse Device Effect
Pyrexia
|
1 Participants
|
|
Adverse Device Effect
Thrombocytopenia
|
1 Participants
|
|
Adverse Device Effect
Troponin increased
|
1 Participants
|
|
Adverse Device Effect
Ventricular extrasystoles
|
1 Participants
|
Adverse Events
Micra Implant Group
Serious events: 12 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Micra Implant Group
n=82 participants at risk
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/82 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Cardiac disorders
Angina unstable
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Cardiac disorders
Arrhythmia
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Cardiac disorders
Cardiac failure
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
General disorders
Pyrexia
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Infections and infestations
Bronchitis
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic angiosarcoma
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Nervous system disorders
Lacunar infarction
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
2.4%
2/82 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
|
Vascular disorders
Arteriovenous fistula
|
1.2%
1/82 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
Other adverse events
| Measure |
Micra Implant Group
n=82 participants at risk
Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
8/82 • Number of events 8 • From implant attempt to last subject follow-up, ranging from 0 to 14 months
Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
|
Additional Information
Weifan Sun, Clinical Study Manager
Medtronic (Shanghai) Management Co., Ltd.
Phone: 021-20325267
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place