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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| His Bundle Pacing | Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| His bundle pacing | Device | Medtronic SelectSecure SureScan MRI model 3830 lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day of implant |
| Changes in His-bundle Pacing Capture Thresholds Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients
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| Name | Affiliation | Role |
|---|---|---|
| Pugazhendhi Vijayaraman, MD | Geisinger Wyoming Valley Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University - Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33478715 | Derived | Vijayaraman P, Dandamudi G, Subzposh FA, Shepard RK, Kalahasty G, Padala SK, Strobel JS, Bauch TD, Ellenbogen KA, Bergemann T, Hughes L, Harris ML, Fagan DH, Yang Z, Koneru JN; IMAGE-HBP Investigators. Imaging-Based Localization of His Bundle Pacing Electrodes: Results From the Prospective IMAGE-HBP Study. JACC Clin Electrophysiol. 2021 Jan;7(1):73-84. doi: 10.1016/j.jacep.2020.07.026. Epub 2020 Sep 30. |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline demographics and medical history were summarized for all subjects with an implant attempt in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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%. | Posted | Number | 95% Confidence Interval | % of subjects with successful implant | Day of implant |
|
Adverse events were collected over a period of 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device capturing issue | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device pacing issue | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nonye Harcourt | Medtronic CRM Clinical | 6122421785 | nonye.o.harcourt@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2018 | Mar 12, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2017 | Mar 12, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2018 | Mar 12, 2021 | ICF_002.pdf |
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The change in the His-bundle pacing capture threshold from implant to 12 months |
| 12 months |
| Changes in Impedance Over Time | To evaluate impedance from implant to 12 months | 12 months |
| Changes in R-wave Amplitude Over Time | To evaluate R-wave amplitude from implant to 12 months | 12 months |
| Changes in QRS Duration Over Time | Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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 | 12 months |
| Geisinger Wyoming Valley Medical Center |
| Wilkes-Barre |
| Pennsylvania |
| 18711 |
| United States |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | United States |
| Did not meet inclusion/exclusion criteria |
|
| Failed HB lead implant |
|
| Received CRT instead |
|
| Exited after lead revision |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| 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) | 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. | Posted | Number | 95% Confidence Interval | odds ratio | Day of implant |
|
|
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| Secondary | Changes in His-bundle Pacing Capture Thresholds Over Time | The change in the His-bundle pacing capture threshold from implant to 12 months | Posted | Mean | Standard Deviation | volts | 12 months |
|
|
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| Secondary | Changes in Impedance Over Time | To evaluate impedance from implant to 12 months | Posted | Mean | Standard Deviation | ohms | 12 months |
|
|
|
| Secondary | Changes in R-wave Amplitude Over Time | To evaluate R-wave amplitude from implant to 12 months | Posted | Mean | Standard Deviation | millivolts | 12 months |
|
|
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| Secondary | Changes in QRS Duration Over Time | Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up | 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. | Posted | Mean | Standard Deviation | milliseconds | 12 months |
|
|
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| 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. | Posted | Number | 95% Confidence Interval | Regression coefficient | 12 months |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Regression coefficient | 12 months |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Regression coefficient | 12 months |
|
|
|
| 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 | Posted | Number | participants | 12 months |
|
|
|
| 0 |
| 69 |
| 3 |
| 69 |
| 3 |
| 69 |
| Device pacing issue | Cardiac disorders | Non-systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | Non-systematic Assessment |
|
Investigator and Participating Institution shall submit any contemplated publication or presentation of this study to Medtronic for review at least 60 days prior to submission, If notified by Medtronic within such 60- day period that such publication or presentation contains Confidential Information, Investigator and Participating Institution each agree to delete Confidential Information, other than Study results, prior to any publication or presentation.