Trial Outcomes & Findings for Imaging Study of Lead Implant for His Bundle Pacing (NCT NCT03294317)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

70 participants

Primary outcome timeframe

Day of implant

Results posted on

2021-06-01

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	70
Overall Study Implanted With Lead at HIS Bundle	61
Overall Study Subjects With Available CT	51
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	1
Overall Study Did not meet inclusion/exclusion criteria	1
Overall Study Failed HB lead implant	8
Overall Study Received CRT instead	1
Overall Study Exited after lead revision	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	His Bundle Pacing n=69 Participants 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
Age, Categorical <=18 years	0 Participants n=69 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=69 Participants
Age, Categorical >=65 years	55 Participants n=69 Participants
Age, Continuous	74 years STANDARD_DEVIATION 12 • n=69 Participants
Sex: Female, Male Female	28 Participants n=69 Participants
Sex: Female, Male Male	41 Participants n=69 Participants
Region of Enrollment United States	69 participants n=69 Participants

PRIMARY outcome

Timeframe: 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%.

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.

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=69 Participants 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
Implant Success	75.36 % of subjects with successful implant Interval 64.04 to 84.01

SECONDARY outcome

Timeframe: 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.

Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=51 Participants 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
Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant Atrial/Ventricular side of TV annulus	1.27 odds ratio Interval 0.24 to 6.58
Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant Above/Below side of CS/RV line	0.57 odds ratio Interval 0.14 to 2.29

SECONDARY outcome

Timeframe: 12 months

The change in the His-bundle pacing capture threshold from implant to 12 months

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=46 Participants 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
Changes in His-bundle Pacing Capture Thresholds Over Time	1.82 volts Standard Deviation 1.03

SECONDARY outcome

Timeframe: 12 months

To evaluate impedance from implant to 12 months

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=47 Participants 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
Changes in Impedance Over Time	429.72 ohms Standard Deviation 79.29

SECONDARY outcome

Timeframe: 12 months

To evaluate R-wave amplitude from implant to 12 months

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=34 Participants 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
Changes in R-wave Amplitude Over Time	4.10 millivolts Standard Deviation 2.15

SECONDARY outcome

Timeframe: 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.

Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=47 Participants 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
Changes in QRS Duration Over Time	105.00 milliseconds Standard Deviation 32.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=45 Participants 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
Association Between Lead Location and Long-term Lead Electrical Performance Atrial/Ventricular side of TV annulus	0.070681015 Regression coefficient Interval -0.587845 to 0.729207
Association Between Lead Location and Long-term Lead Electrical Performance Above/Below side of CS/RV line	0.106436807 Regression coefficient Interval -0.439328 to 0.652202

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=45 Participants 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
Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance	0.308729841 Regression coefficient Interval 0.008103 to 0.609357

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=45 Participants 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
Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance	-0.001329355 Regression coefficient Interval -0.012422 to 0.009763

SECONDARY outcome

Timeframe: 12 months

Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized

Outcome measures

Outcome measures
Measure	His Bundle Pacing n=69 Participants 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
Complications Related to the Procedure or the Lead for His Bundle Pacing	4 participants

Adverse Events

His Bundle Pacing

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	His Bundle Pacing n=69 participants at risk 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
Cardiac disorders Device capturing issue	1.4% 1/69 • Number of events 1 • Adverse events were collected over a period of 12 months
Cardiac disorders Device pacing issue	2.9% 2/69 • Number of events 2 • Adverse events were collected over a period of 12 months

Other adverse events

Other adverse events
Measure	His Bundle Pacing n=69 participants at risk 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
Cardiac disorders Device pacing issue	1.4% 1/69 • Number of events 1 • Adverse events were collected over a period of 12 months
Cardiac disorders Bundle branch block right	2.9% 2/69 • Number of events 2 • Adverse events were collected over a period of 12 months

Additional Information

Nonye Harcourt

Medtronic CRM Clinical

Phone: 6122421785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER