BradycardiaINSIGHT-LBBANCT06014866
Conduction System Pacing With INGEVITY+
An observational study of Bradycardia, run by Duke University at 8 sites in United States.
Trial summary
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA). Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Cardiac pacing
- Type of treatment
- Medical device
- How many people
- 1,383 participants
- Where
- 8 sitesUnited States
- Study dates
- 13 Nov 2023to 27 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with an INGEVITY+ lead implanted in the LBBA to provide rate support for bradycardia.
Who may be able to join
- De novo anti-bradycardia pacing pacemaker implant.
- INGEVITY+ lead implant attempt in the LBBA as documented in the medical record at least 90 days ago.
- LBBAP implant attempt employed a Boston Scientific SSPC series sheath
Who cannot join
- -ICD and CRT-D devices
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Chicago
Chicago, Illinois, 60637
TriHealth Bethesda North Hospital
Cincinnati, Ohio, 45242
Essentia Health - Saint Mary's Duluth Clinic
Duluth, Minnesota, 55805
Duke University
Durham, North Carolina, 27708
NewYork-Presbyterian Queens
Flushing, New York, 11355
Community Heart And Vascular Hospital
Indianapolis, Indiana, 46227
Sarasota Memorial Health Care System
Sarasota, Florida, 34233
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479
About this study
Official title: ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
Read the detailed description
INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide complication free rate (safety) and lead measurements (performance).
Data will be gathered by means of a retrospective, multi-center, US only observational chart review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing thresholds and R-wave amplitude. Consecutive implants will be collected from each site for evaluating the endpoints.
- Conditions
- Bradycardia
- Being tested
- Cardiac pacing
- Keywords
- Conduction system pacing, Cardiac physiologic pacing
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac pacingDevice
Patient's previously implanted with the INGEVITY+ lead located in the LBBA
| Study group | Role | What they receive |
|---|---|---|
| LBBA INGEVITY+ Pacing | Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA. Receives: Device: Cardiac pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead-Related Complication Free Rate
Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.
Measured: Implant through 90 days
Pacing Threshold
Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.
Measured: Implant through 90 days
Sensed R-wave amplitude
Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.
Measured: Implant through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start13 Nov 2023
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Retrospective
- Enrolment
- 1,383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Daniel Friedman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014866
- Sponsor's protocol ID
- Pro00113475
- Acronym
- INSIGHT-LBBA
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2023
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Friedman DJ, Shadrin I, Goldbarg S, Trulock KM, Patel A, Loring Z, Coles SA, Gandhi G, Upadhyay GA, Wold N, Jones PW, Ruble SB, Weinstock J, Latanich CA. Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA. Heart Rhythm. 2025 Aug;22(8):2047-2054. doi: 10.1016/j.hrthm.2025.01.041. Epub 2025 Feb 4.
PubMed 39914662
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area
- ClinicalTrials.gov ID
- NCT06014866
- Acronym / sponsor ID
- INSIGHT-LBBA / Pro00113475
- Conditions
- Bradycardia
- Keywords
- Conduction system pacing, Cardiac physiologic pacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,383 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
Detailed description
INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide complication free rate (safety) and lead measurements (performance).
Data will be gathered by means of a retrospective, multi-center, US only observational chart review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing thresholds and R-wave amplitude. Consecutive implants will be collected from each site for evaluating the endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBBA INGEVITY+ Pacing | – | Device: Cardiac pacingPatients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with an INGEVITY+ lead implanted in the LBBA to provide rate support for bradycardia.
Key inclusion criteria (3 listed)
- De novo anti-bradycardia pacing pacemaker implant.
- INGEVITY+ lead implant attempt in the LBBA as documented in the medical record at least 90 days ago.
- LBBAP implant attempt employed a Boston Scientific SSPC series sheath
Key exclusion criteria (1 listed)
- -ICD and CRT-D devices
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 |
|---|---|---|
| Cardiac pacingPatient's previously implanted with the INGEVITY+ lead located in the LBBA | Device | LBBA INGEVITY+ Pacing |
Primary outcome
Lead-Related Complication Free Rate
Time frame: Implant through 90 days
Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.
Pacing Threshold
Time frame: Implant through 90 days
Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.
Sensed R-wave amplitude
Time frame: Implant through 90 days
Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Results publication: PubMed 39914662Friedman DJ, Shadrin I, Goldbarg S, Trulock KM, Patel A, Loring Z, Coles SA, Gandhi G, Upadhyay GA, Wold N, Jones PW, Ruble SB, Weinstock J, Latanich CA. Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA. Heart Rhythm. 2025 Aug;22(8):2047-2054. doi: 10.1016/j.hrthm.2025.01.041. Epub 2025 Feb 4.
- 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.
Daniel Friedman, MD principal investigator
Duke University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Duke University at 8 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 3 inclusion and 1 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 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lead-Related Complication Free Rate (time frame: Implant through 90 days). The study lists 3 primary outcomes in all. 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 NCT06014866, 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 23 May 2025.