Cardiac Pacemaker, Artificial
Conditions
Keywords
His bundle pacing, Pacemaker
Brief summary
The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.
Detailed description
The study will evaluate implant lead electrical measurements and changes over time, estimate the correlation between lead location and selective vs non-selective His bundle pacing, and estimate the correlation between long-term lead performance and implant characteristics. Data from the study may be used to standardize the implant workflow to help improve the ease and predictability of His bundle pacing implants.
Interventions
DEVICEHis bundle pacing
Medtronic SelectSecure SureScan MRI model 3830 lead
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a Class I or II indication for implantation of an implantable pacemaker * Subject (or legally authorized representative) has signed and dated the study-specific Consent Form * Subject is 18 years of age or older, or is of legal age to give informed consent per local and national law * Subject is expected to remain available for follow-up visits
Exclusion criteria
* Subject is contraindicated for Cardiac CT * Subject has an existing or prior pacemaker, ICD or CRT device implant * Subject is intended to receive an implant of a LV lead or CRT device * Subject life expectancy is less than 1 year * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Success | Day of implant | To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in His-bundle Pacing Capture Thresholds Over Time | 12 months | The change in the His-bundle pacing capture threshold from implant to 12 months |
| Changes in Impedance Over Time | 12 months | To evaluate impedance from implant to 12 months |
| Changes in R-wave Amplitude Over Time | 12 months | To evaluate R-wave amplitude from implant to 12 months |
| Changes in QRS Duration Over Time | 12 months | Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up |
| Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant | Day of implant | Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective) |
| Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance | 12 months | To assess the correlation between His-bundle pacing capture threshold at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant. |
| Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance | 12 months | To assess the correlation between paced QRS duration at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant. |
| Complications Related to the Procedure or the Lead for His Bundle Pacing | 12 months | Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized |
| Association Between Lead Location and Long-term Lead Electrical Performance | 12 months | To assess the association between lead location and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant. |
Countries
United States
Participant flow
Recruitment details
70 subjects signed consent. Per the protocol , a subject is considered enrolled in the study upon signing and dating the informed consent. Of the 70 who signed informed consent, 69 were considered enrolled per the protocol. 1 was screen failure, i.e they signed informed consent, but ended up failing inclusion/exclusion
Pre-assignment details
Of the 70 subjects who signed informed consent, 1 failed inclusion/exclusion criteria and was exited from the study and left us with 69 subjects. 8 of the 69 subjects were Implant Attempted i.e they failed HB lead implant and was exited from the study. 61 subjects had the lead placed at the His-bundle and for various reasons, such as lost to follow-up, physician decision, subject withdrew, received CRT 11 of the subjects were exited leaving us with 50 subjects who completed the study.
Participants by arm
| Arm | Count |
|---|---|
| His Bundle Pacing Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion/exclusion criteria | 1 |
| Overall Study | Exited after lead revision | 2 |
| Overall Study | Failed HB lead implant | 8 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Received CRT instead | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | His Bundle Pacing | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 55 Participants | — |
| Age, Categorical Between 18 and 65 years | 14 Participants | — |
| Age, Continuous | 74 years STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 69 participants | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 41 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 3 / 69 |
| serious Total, serious adverse events | 3 / 69 |
Outcome results
Primary
Implant Success
To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms.
Time frame: Day of implant
Population: The primary objective is to assess the implant success proportion of the Medtronic Model 3830 pacing lead at the bundle of His for His Bundle Pacing. The observed implant success proportion was calculated as follows:~Implant Success Proportion= ( # Subjects with implant success)/( # Subjects with implant attempt) The observed implant success proportion was 75.36% and the 95% confidence interval is 64.04% - 84.01%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| His Bundle Pacing | Implant Success | 75.36 % of subjects with successful implant |
Secondary
Association Between Lead Location and Long-term Lead Electrical Performance
To assess the association between lead location and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| His Bundle Pacing | Association Between Lead Location and Long-term Lead Electrical Performance | Atrial/Ventricular side of TV annulus | 0.070681015 Regression coefficient |
| His Bundle Pacing | Association Between Lead Location and Long-term Lead Electrical Performance | Above/Below side of CS/RV line | 0.106436807 Regression coefficient |
Secondary
Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant
Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)
Time frame: Day of implant
Population: The lead position is analyzed using two variables. The first variable is whether the lead tip is on the atrial or ventricular side of the TV annulus. The second variable is whether the lead tip is above or below the CS line, on the atrial side, or the RV line, on the ventricular side of the TV. The relationship between lead position was assessed using a logistic regression where the dependent variable was HB pacing type and the independent variables were the two lead position variables.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| His Bundle Pacing | Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant | Atrial/Ventricular side of TV annulus | 1.27 odds ratio |
| His Bundle Pacing | Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant | Above/Below side of CS/RV line | 0.57 odds ratio |
Secondary
Changes in His-bundle Pacing Capture Thresholds Over Time
The change in the His-bundle pacing capture threshold from implant to 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| His Bundle Pacing | Changes in His-bundle Pacing Capture Thresholds Over Time | 1.82 volts | Standard Deviation 1.03 |
Secondary
Changes in Impedance Over Time
To evaluate impedance from implant to 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| His Bundle Pacing | Changes in Impedance Over Time | 429.72 ohms | Standard Deviation 79.29 |
Secondary
Changes in QRS Duration Over Time
Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up
Time frame: 12 months
Population: The QRS duration measurements evaluated include both intrinsic, paced QRS duration during pacing threshold testing, and paced QRS duration at final programming. Longitudinal analysis was conducted to estimate differences in QRS duration measurements from implant to subsequent follow-up visits using a mixed effects model.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| His Bundle Pacing | Changes in QRS Duration Over Time | 105.00 milliseconds | Standard Deviation 32.05 |
Secondary
Changes in R-wave Amplitude Over Time
To evaluate R-wave amplitude from implant to 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| His Bundle Pacing | Changes in R-wave Amplitude Over Time | 4.10 millivolts | Standard Deviation 2.15 |
Secondary
Complications Related to the Procedure or the Lead for His Bundle Pacing
Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| His Bundle Pacing | Complications Related to the Procedure or the Lead for His Bundle Pacing | 4 participants |
Secondary
Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance
To assess the correlation between His-bundle pacing capture threshold at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| His Bundle Pacing | Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance | 0.308729841 Regression coefficient |
Secondary
Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance
To assess the correlation between paced QRS duration at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| His Bundle Pacing | Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance | -0.001329355 Regression coefficient |