Imaging Study of Lead Implant for His Bundle Pacing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-29

Study Completion Date

2020-01-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Pacemaker, Artificial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type DEVICE

Medtronic SelectSecure SureScan MRI model 3830 lead

Interventions

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His bundle pacing

Medtronic SelectSecure SureScan MRI model 3830 lead

Intervention Type DEVICE

Eligibility Criteria

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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
* Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
* Subject is enrolled in a concurrent study that may confound the results of this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No