Bradycardia
Conditions
Keywords
Transcatheter Pacing System, Micra Implantable Device, Transfermoral Catheter Delivery System
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.
Interventions
DEVICEMicra Transcatheter Pacing System (TPS)
Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Major Complications Free Survival Probability | 6 months post implant | Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensing Amplitude | 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. |
| Adverse Device Effect | From implant attempt to last subject follow-up, ranging from 0 to 14 months | Adverse event related to the Micra system or implant procedure |
| Pacing Capture Threshold (PCT) | 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. |
| Impedance | Implant, Discharge, Month 1, Month 3, Month 6 | Impedance measured from the Micra device Impedance is the opposition to current flow. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unsuccessful Implant | 1 |
Baseline characteristics
| Characteristic | Micra Implant Group |
|---|---|
| Age, Continuous | 68.50 years STANDARD_DEVIATION 11.72 |
| BMI | 24.0 kg/m^2 STANDARD_DEVIATION 3.89 |
| Race/Ethnicity, Customized Ethinic Chinese | 82 Participants |
| Region of Enrollment China | 82 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 82 |
| other Total, other adverse events | 8 / 82 |
| serious Total, serious adverse events | 12 / 82 |
Outcome results
Primary
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
Time frame: 6 months post implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micra Implant Group | Percentage of Participants With Major Complications Free Survival Probability | 97.6 percentage of participants |
Comparison: Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%.p-value: 0.002195% CI: [90.6, 99.4]z test, 1-sided
Secondary
Adverse Device Effect
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
Population: All enrolled patients with an implant attempt
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Micra Implant Group | Adverse Device Effect | Anaemia | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Myocardial necrosis marker increased | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Oedema peripheral | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Pyrexia | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Thrombocytopenia | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Troponin increased | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Ventricular extrasystoles | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Arteriovenous fistula | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Bundle branch block right | 3 Participants |
| Micra Implant Group | Adverse Device Effect | Chest pain | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Deep vein thrombosis | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Device pacing issue | 1 Participants |
| Micra Implant Group | Adverse Device Effect | Dizziness | 1 Participants |
Secondary
Impedance
Impedance measured from the Micra device Impedance is the opposition to current flow.
Time frame: Implant, Discharge, Month 1, Month 3, Month 6
Population: 81 subject with successful implant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Micra Implant Group | Impedance | Implant | 873.83 Ohms | Standard Deviation 228.26 |
| Micra Implant Group | Impedance | Discharge | 781.73 Ohms | Standard Deviation 193.85 |
| Micra Implant Group | Impedance | 1 Month | 719.38 Ohms | Standard Deviation 142.27 |
| Micra Implant Group | Impedance | 3 Months | 659.01 Ohms | Standard Deviation 130.04 |
| Micra Implant Group | Impedance | 6 Months | 632.22 Ohms | Standard Deviation 124.68 |
Secondary
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.
Time frame: Implant, Discharge, Month 1, Month 3, Month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Micra Implant Group | Pacing Capture Threshold (PCT) | 6 Months | 0.50 Volts | Standard Deviation 0.32 |
| Micra Implant Group | Pacing Capture Threshold (PCT) | Implant | 0.52 Volts | Standard Deviation 0.29 |
| Micra Implant Group | Pacing Capture Threshold (PCT) | Discharge | 0.52 Volts | Standard Deviation 0.43 |
| Micra Implant Group | Pacing Capture Threshold (PCT) | 1 Month | 0.50 Volts | Standard Deviation 0.57 |
| Micra Implant Group | Pacing Capture Threshold (PCT) | 3 Months | 0.47 Volts | Standard Deviation 0.3 |
Secondary
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.
Time frame: Implant, Discharge, Month 1, Month 3, Month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Micra Implant Group | Sensing Amplitude | Implant | 9.41 mV | Standard Deviation 3.87 |
| Micra Implant Group | Sensing Amplitude | Discharge | 11.16 mV | Standard Deviation 3.88 |
| Micra Implant Group | Sensing Amplitude | 1 Month | 13.53 mV | Standard Deviation 3.65 |
| Micra Implant Group | Sensing Amplitude | 3 Months | 13.78 mV | Standard Deviation 4.05 |
| Micra Implant Group | Sensing Amplitude | 6 Months | 13.87 mV | Standard Deviation 4.18 |