Heart FailureNCT07206602
AI-Guided Left Bundle Branch Area Pacing
A study testing AI-assisted Left Bundle Branch Area Pacing and Left Bundle Branch Area Pacing in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of AI-guided LBBAP versus conventional LBBAP (not AI-guided) in improving CRT response rates and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- AI-assisted Left Bundle Branch Area Pacing and Left Bundle Branch Area Pacing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age: 18 years or older.
- Left Ventricular Ejection Fraction (LVEF): <50% within 6 months prior to enrollment.
- QRS Duration: Resting QRS duration ≥ 130 ms on ECG OR anticipated right ventricular pacing > 40% OR device in place with right ventricular pacing > 40% within 6 months prior to enrollment.
- Medical Therapy: Optimized on guideline-directed medical therapy for heart failure.
- AI-ECG probability of low LVEF: >0.5
Who cannot join
- Age less than 18 years old
- Inability to follow-up
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Fatima M Ezzeddine, M.D.
About this study
Official title: A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure
The purpose of this study is to compare the effectiveness of AI-guided LBBAP versus conventional LBBAP (not AI-guided) in improving CRT response rates and clinical outcomes.
- Conditions
- Heart Failure
- Being tested
- AI-assisted Left Bundle Branch Area Pacing, Left Bundle Branch Area Pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted Left Bundle Branch Area PacingDevice
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology
Left Bundle Branch Area PacingProcedure or surgery
Patients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure
| Study group | Role | What they receive |
|---|---|---|
| AI-guided | Experimental | Not described Receives: Device: AI-assisted Left Bundle Branch Area Pacing |
| Control | Active comparator | Not described Receives: Procedure: Left Bundle Branch Area Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT response rate
CRT response is defined as an absolute increase of >5% in left ventricular ejection fraction (LVEF) after 6 months of CRT
Measured: Baseline, 6 months
Secondary outcomes (12)
NYHA (New York Heart Association) Class
The New York Heart Association (NYHA) classification will be assessed using the NYHA questionnaire, which evaluates the extent of physical limitations caused by heart failure. This system categorizes patients into one of four classes, with higher classes indicating more severe functional impairment.
Measured: Baseline, 6 months
Number of Hospitalizations
Number of Hospitalizations will be determined by the number of participants that are hospitalized for heart failure.
Measured: 6 months
Number of Deaths
Number of patient deaths by any cause
Measured: 6 months
Left Ventricular Linear Dimensions
Left Ventricular Linear Dimensions will be measured by an echocardiogram. A lower value indicates better cardiac function.
Measured: Baseline, 3 months
Left Ventricular Linear Volume
Left Ventricular Linear Volume will be measured by an echocardiogram. A lower value indicates better cardiac function.
Measured: Baseline, 3 months
Procedural success: LBBAP-conventional arm
LBBAP is considered successful if unipolar paced QRS morphology demonstrated a Qr or qR morphology in lead V1 along with any 1 of the following criteria:
- Left bundle branch potential
- Transition to selective left bundle branch capture or left ventricular septal capture during threshold testing or programmed stimulation
- R-wave peak time <90 ms in V5-V6
- V6-V1 interpeak interval >44 ms
Measured: Baseline
Procedural success: AI-LBBAP arm
Procedural success is defined as improvement in the AI-ECG predicted likelihood of having a low LVEF from greater than 0.5 at baseline to less than 0.5 after LBBAP.
Measured: Baseline
Fluoroscopy time
Fluoroscopy time will be determined by the amount of time that fluoroscopy is used to guide the left bundle branch area pacing (an average of 30 minutes)
Measured: Baseline, Approximately 30 minutes
Total procedure time
Total procedure time will be determined by the start of the LBBAP procedure until completion (an average of 2 hours)
Measured: Baseline, Approximately 1-2 hours
Lead pacing thresholds
Lead pacing thresholds will be measured in Voltage at millisecond.
Measured: Baseline
Impedance
Impedance will be measured in Ohms.
Measured: Baseline
Sensing Parameters
Sensing Parameters will be measured in mV (milliVolts)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start23 Jan 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
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 Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima M. Ezzeddine, Mayo Clinic
- Investigators
- Fatima Ezzeddine, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206602
- Sponsor's protocol ID
- 25-007700
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure
- ClinicalTrials.gov ID
- NCT07206602
- Acronym / sponsor ID
- 25-007700
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Oct 2025 (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 purpose of this study is to compare the effectiveness of AI-guided LBBAP versus conventional LBBAP (not AI-guided) in improving CRT response rates and clinical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-guided | Experimental | Device: AI-assisted Left Bundle Branch Area Pacing |
| Control | Active comparator | Procedure: Left Bundle Branch Area Pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years or older.
- Left Ventricular Ejection Fraction (LVEF): <50% within 6 months prior to enrollment.
- QRS Duration: Resting QRS duration ≥ 130 ms on ECG OR anticipated right ventricular pacing > 40% OR device in place with right ventricular pacing > 40% within 6 months prior to enrollment.
- Medical Therapy: Optimized on guideline-directed medical therapy for heart failure.
- AI-ECG probability of low LVEF: >0.5
Key exclusion criteria (3 listed)
- Age less than 18 years old
- Inability to follow-up
- Pregnancy
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 |
|---|---|---|
| AI-assisted Left Bundle Branch Area PacingPatients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure using AI assisted technology | Device | AI-guided |
| Left Bundle Branch Area PacingPatients will undergo a Left Bundle Branch Area Pacing (LBBAP) procedure | Procedure or surgery | Control |
Primary outcome
CRT response rate
Time frame: Baseline, 6 months
CRT response is defined as an absolute increase of >5% in left ventricular ejection fraction (LVEF) after 6 months of CRT
12 secondary outcomes
NYHA (New York Heart Association) Class
Time frame: Baseline, 6 months
Number of Hospitalizations
Time frame: 6 months
Number of Deaths
Time frame: 6 months
Left Ventricular Linear Dimensions
Time frame: Baseline, 3 months
Left Ventricular Linear Volume
Time frame: Baseline, 3 months
Procedural success: LBBAP-conventional arm
Time frame: Baseline
Procedural success: AI-LBBAP arm
Time frame: Baseline
Fluoroscopy time
Time frame: Baseline, Approximately 30 minutes
Total procedure time
Time frame: Baseline, Approximately 1-2 hours
Lead pacing thresholds
Time frame: Baseline
Impedance
Time frame: Baseline
Sensing Parameters
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
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.
Fatima Ezzeddine principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted Left Bundle Branch Area Pacing and Left Bundle Branch Area Pacing in people with Heart Failure, run by Mayo Clinic 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 5 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Abdel Messih (507-422-3967, mansour.joseph@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT response rate (time frame: Baseline, 6 months). 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 18 Feb 2026.