Heart FailureMAP HIS HFNCT03803995
Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
A study testing Mapping and Pacing the His Bundle and Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing in people with Heart Failure and Left Bundle-Branch Block, run by Abbott Medical Devices at 1 site in United States.
Trial summary
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Bundle-Branch Block
- What is being tested?
- Mapping and Pacing the His Bundle and Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 26 Apr 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
- An ECG with a wide QRS complex (>130 ms)
- ECG morphology of typical complete LBBB,
- Patients have heart failure with NYHA Class II-IV symptoms,
- LV EF <50%
- At least 18 years old and not pregnant.
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- Must provide written informed consent prior to any clinical investigation related procedure.
- Willing to comply with study evaluation requirements
- Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.)
Who cannot join
- Patients have non-specific intraventricular conduction delay or right bundle branch block
- Previously implanted cardiac devices with three or more permanent leads
- History of aortic valve repair or replacement
- History of tricuspid valve replacement
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacemaker or CRT implant in the opinion of the investigator
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Being tested
- Mapping and Pacing the His Bundle, Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapping and Pacing the His BundleProcedure or surgery
During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.
Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacingProcedure or surgery
During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.
| Study group | Role | What they receive |
|---|---|---|
| Mapping and Pacing the His Bundle | Other | All patients will be in this arm. Mapping and Pacing the His Bundle will be performed. Receives: Procedure: Mapping and Pacing the His Bundle; Procedure: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful HB pacing sites
Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.
Measured: At device implant procedure
Secondary outcomes (7)
Success rate of HB pacing
Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure;
Measured: At device implant procedure
Ventricular activation during HB pacing
Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure;
Measured: At device implant procedure
Echocardiographic measurements of LV ejection fraction
Collect echo measurements of LV ejection fraction at three-month follow-up visit
Measured: At three-month follow-up
Echocardiographic measurements of LV end-systolic volume
Collect echo measurements of LV end-systolic volume at three-month follow-up visit
Measured: At three-month follow-up
Capture threshold of HB pacing
Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant
Measured: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Lead impedance of HB pacing lead
Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant
Measured: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Sensing amplitude of HB pacing lead
Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant
Measured: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start20 Mar 2019
- Primary completion20 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT03803995
- Sponsor's protocol ID
- CRD 969
- Acronym
- MAP HIS HF
- Status last verified
- Sep 2025
- First submitted
- 4 Jan 2019
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
- ClinicalTrials.gov ID
- NCT03803995
- Acronym / sponsor ID
- MAP HIS HF / CRD 969
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 15 Jan 2019 (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 prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mapping and Pacing the His Bundle | Other | Procedure: Mapping and Pacing the His Bundle, Procedure: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacingAll patients will be in this arm. Mapping and Pacing the His Bundle will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
- An ECG with a wide QRS complex (>130 ms)
- ECG morphology of typical complete LBBB,
- Patients have heart failure with NYHA Class II-IV symptoms,
- LV EF <50%
Key exclusion criteria (7 listed)
- Patients have non-specific intraventricular conduction delay or right bundle branch block
- Previously implanted cardiac devices with three or more permanent leads
- History of aortic valve repair or replacement
- History of tricuspid valve replacement
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
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 |
|---|---|---|
| Mapping and Pacing the His BundleDuring the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers. | Procedure or surgery | Mapping and Pacing the His Bundle |
| Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacingDuring the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers. | Procedure or surgery | Mapping and Pacing the His Bundle |
Primary outcome
Successful HB pacing sites
Time frame: At device implant procedure
Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.
7 secondary outcomes
Success rate of HB pacing
Time frame: At device implant procedure
Ventricular activation during HB pacing
Time frame: At device implant procedure
Echocardiographic measurements of LV ejection fraction
Time frame: At three-month follow-up
Echocardiographic measurements of LV end-systolic volume
Time frame: At three-month follow-up
Capture threshold of HB pacing
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Lead impedance of HB pacing lead
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Sensing amplitude of HB pacing lead
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
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 2 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mapping and Pacing the His Bundle and Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing in people with Heart Failure and Left Bundle-Branch Block, run by Abbott Medical Devices at 1 site 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 9 inclusion and 7 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Successful HB pacing sites (time frame: At device implant procedure). 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 2 Oct 2025.