Sick Sinus SyndromeNCT03564860
HBP Device EGM Data Collection
An observational study of Sick Sinus Syndrome and AV Block, run by Abbott Medical Devices at 3 sites in United States.
Trial summary
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome, AV Block, Heart Failure
- What is being tested?
- Device data collection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jul 2018to 30 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The intended population for this clinical investigation consists of patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device.
Who may be able to join
- Has previously implanted with Abbott device and any pacing lead at HB
- Age ≥ 18 years
- Ability to provide informed consent for study participation
- Willing to comply with study evaluation requirements
Who cannot join
- Suspected pacing system failure
- Lead impedance out of range
- Ventricular sensing amplitude lower than 0.5 mV
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Greenville Health System
Greenville, South Carolina, 29605
*Heart Center Research, LLC.
Huntsville, Alabama, 35801
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania, 18840
About this study
Official title: His Bundle Pacing Device Electrogram Data Collection
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.
Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.
The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.
- Conditions
- Sick Sinus Syndrome, AV Block, Heart Failure
- Being tested
- Device data collection
- Medical subject headings
- Sick Sinus Syndrome, Atrioventricular Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device data collectionProcedure or surgery
Collection of device electrograms and 12-lead ECG during a device follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| HBP device data collection group | Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit. Receives: Procedure: Device data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of device electrogram
Mean amplitude of device electrogram during His bundle pacing
Measured: through study completion, an average of 1 year
Duration of device electrogram
Mean duration of device electrogram during His bundle pacing
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start17 Jul 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564860
- Sponsor's protocol ID
- ABT-CIP-10234
- Status last verified
- Oct 2020
- First submitted
- 15 May 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- His Bundle Pacing Device Electrogram Data Collection
- ClinicalTrials.gov ID
- NCT03564860
- Acronym / sponsor ID
- ABT-CIP-10234
- Conditions
- Sick Sinus Syndrome, AV Block, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 21 Jun 2018 (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.
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.
Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.
The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBP device data collection group | – | Procedure: Device data collectionDevice electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended population for this clinical investigation consists of patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device.
Key inclusion criteria (4 listed)
- Has previously implanted with Abbott device and any pacing lead at HB
- Age ≥ 18 years
- Ability to provide informed consent for study participation
- Willing to comply with study evaluation requirements
Key exclusion criteria (3 listed)
- Suspected pacing system failure
- Lead impedance out of range
- Ventricular sensing amplitude lower than 0.5 mV
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 |
|---|---|---|
| Device data collectionCollection of device electrograms and 12-lead ECG during a device follow-up visit | Procedure or surgery | HBP device data collection group |
Primary outcome
Amplitude of device electrogram
Time frame: through study completion, an average of 1 year
Mean amplitude of device electrogram during His bundle pacing
Duration of device electrogram
Time frame: through study completion, an average of 1 year
Mean duration of device electrogram during His bundle pacing
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 8 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sick Sinus Syndrome and AV Block, run by Abbott Medical Devices 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 3 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 8 Oct 2020. 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?
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?
Amplitude of device electrogram (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.