NCT03294317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 1, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

September 22, 2017

Results QC Date

April 13, 2021

Last Update Submit

May 28, 2021

Conditions

Cardiac Pacemaker, Artificial

Keywords

His bundle pacingPacemaker

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant

    Day of implant

  • Changes in His-bundle Pacing Capture Thresholds Over Time

    12 months

  • Changes in Impedance Over Time

    12 months

  • Changes in R-wave Amplitude Over Time

    12 months

  • Changes in QRS Duration Over Time

    12 months

  • +4 more secondary outcomes

Study Arms (1)

His Bundle Pacing

Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.

Device: His bundle pacing

Interventions

His bundle pacingDEVICE

Medtronic SelectSecure SureScan MRI model 3830 lead

His Bundle Pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indiana University - Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 33478715DERIVED

Results Point of Contact

Title
Nonye Harcourt
Organization
Medtronic CRM Clinical
nonye.o.harcourt@medtronic.com
6122421785

Study Officials

  • Pugazhendhi Vijayaraman, MD

    Geisinger Wyoming Valley Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 27, 2017

Study Start

November 29, 2017

Primary Completion

April 24, 2019

Study Completion

January 24, 2020

Last Updated

June 1, 2021

Results First Posted

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)