Cardiac Pacemaker, Artificial(IMAGE-HBP)NCT03294317
Imaging Study of Lead Implant for His Bundle Pacing
An observational study of Cardiac Pacemaker, Artificial, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacemaker, Artificial
- What is being tested?
- His bundle pacing
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Nov 2017to 24 Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients
Who may be able to join
- 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
Who cannot join
- 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 exclusion criteria required by local law (e.g. age or other)
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University - Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: Imagining Study of Lead Implant for His Bundle Pacing
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.
Read the 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.
- Conditions
- Cardiac Pacemaker, Artificial
- Being tested
- His bundle pacing
- Keywords
- His bundle pacing, Pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
His bundle pacingDevice
Medtronic SelectSecure SureScan MRI model 3830 lead
| Study group | Role | What they receive |
|---|---|---|
| His Bundle Pacing | Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted. Receives: Device: His bundle pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of implant
Secondary outcomes (9)
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)
Measured: Day of implant
Changes in His-bundle Pacing Capture Thresholds Over Time
The change in the His-bundle pacing capture threshold from implant to 12 months
Measured: 12 months
Changes in Impedance Over Time
To evaluate impedance from implant to 12 months
Measured: 12 months
Changes in R-wave Amplitude Over Time
To evaluate R-wave amplitude from implant to 12 months
Measured: 12 months
Changes in QRS Duration Over Time
Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start29 Nov 2017
- Primary completion24 Apr 2019
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Pacemaker, ArtificialStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pugazhendhi Vijayaraman, MD, Principal investigator, Geisinger Wyoming Valley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294317
- Sponsor's protocol ID
- IMAGE-HBP
- Acronym
- (IMAGE-HBP)
- Status last verified
- May 2021
- First submitted
- 22 Sep 2017
- Last updated
- 1 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33478715
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagining Study of Lead Implant for His Bundle Pacing
- ClinicalTrials.gov ID
- NCT03294317
- Acronym / sponsor ID
- (IMAGE-HBP) / IMAGE-HBP
- Conditions
- Cardiac Pacemaker, Artificial
- Keywords
- His bundle pacing, Pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 1 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| His Bundle Pacing | – | Device: His bundle pacingPatient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| His bundle pacingMedtronic SelectSecure SureScan MRI model 3830 lead | Device | His Bundle Pacing |
Primary outcome
Implant Success
Time frame: 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.
9 secondary outcomes
Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant
Time frame: Day of implant
Changes in His-bundle Pacing Capture Thresholds Over Time
Time frame: 12 months
Changes in Impedance Over Time
Time frame: 12 months
Changes in R-wave Amplitude Over Time
Time frame: 12 months
Changes in QRS Duration Over Time
Time frame: 12 months
Association Between Lead Location and Long-term Lead Electrical Performance
Time frame: 12 months
Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance
Time frame: 12 months
Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance
Time frame: 12 months
Complications Related to the Procedure or the Lead for His Bundle Pacing
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33478715Vijayaraman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pugazhendhi Vijayaraman, MD principal investigator
Geisinger Wyoming Valley Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Pacemaker, Artificial, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Success (time frame: Day of implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.