Heart FailureACHIEVED LBBAPNCT07526896
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
A study testing LBBAP Therapy, LOT-CRT and ICD in people with Heart Failure and Systolic Bundle Branch Block, Left, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in United States.
Trial summary
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic Bundle Branch Block, Left
- What is being tested?
- LBBAP Therapy, LOT-CRT and ICD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2026to Sep 2029
- 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
- Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.
- Subject has documented LVEF ≤ 35% within 60 days of enrollment.
- Subject meets the criteria for presence of Strauss-defined LBBB.
- Subject meets NYHA classification II or III.
- Subject is willing and able to provide written consent.
- Subject is at least 18 years of age at the time of consent.
- Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.
- The subject's medical records must be accessible by the enrolling site over the follow-up period.
Who cannot join
- Subject has documented myocardial infarction before enrollment.
- Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.
- Subject has 2nd or 3rd degree AV block.
- Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).
- Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
- Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.
Show all 17Show fewer
- Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).
- Subject underwent valve surgery within 90 days prior to enrollment.
- Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.
- Subject is post-heart transplantation or is actively listed on the transplantation list.
- Subject is implanted with a left ventricular assist device (LVAD).
- Subject has severe renal disease.
- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.
- Subject has complex and uncorrected congenital heart disease.
- Subject has life expectancy of less than 12 months.
- Subject is pregnant or breastfeeding.
- Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
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
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Ellen Thomas
John Zakaib
About this study
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis
- Conditions
- Heart Failure, Systolic Bundle Branch Block, Left
- Being tested
- LBBAP Therapy, LOT-CRT, ICD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBBAP TherapyDevice
CRT-D programmed for LBBAP (LV lead OFF)
LOT-CRTDevice
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
ICDDevice
ICD programmed for LBBAP
LOT-CRTDevice
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | LBBAP therapy for 6 months followed by LOT-CRT for 6 months Receives: Device: LBBAP Therapy; Device: LOT-CRT |
| Sequence 2 | Experimental | LOT-CRT for 6 months followed by LBBAP therapy for 6 months Receives: Device: LBBAP Therapy; Device: LOT-CRT |
| Observational Treatment Arm | Experimental | Not described Receives: Device: ICD; Device: LOT-CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
Measured: Baseline, 6 months, 12 months
Left ventricular end-systolic volume (LVESV)
Change in LVESV assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
Measured: Baseline, 6 months, 12 months
Secondary outcomes (2)
Left ventricular ejection fraction (LVEF)
Change in LVEF assessed by echocardiography from baseline to 6 months
Measured: Baseline, 6 months
Left ventricular end-systolic volume (LVESV)
Change in LVESV assessed by echocardiography from baseline to 6 months.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start13 Oct 2026
- Primary completionJul 2029 (estimated)
- Study completionSep 2029 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526896
- Sponsor's protocol ID
- MDT25031
- Acronym
- ACHIEVED LBBAP
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
- ClinicalTrials.gov ID
- NCT07526896
- Acronym / sponsor ID
- ACHIEVED LBBAP / MDT25031
- Conditions
- Heart Failure, Systolic Bundle Branch Block, Left
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 Apr 2026 (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 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: LBBAP Therapy, Device: LOT-CRTLBBAP therapy for 6 months followed by LOT-CRT for 6 months |
| Sequence 2 | Experimental | Device: LBBAP Therapy, Device: LOT-CRTLOT-CRT for 6 months followed by LBBAP therapy for 6 months |
| Observational Treatment Arm | Experimental | Device: ICD, Device: LOT-CRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.
- Subject has documented LVEF ≤ 35% within 60 days of enrollment.
- Subject meets the criteria for presence of Strauss-defined LBBB.
- Subject meets NYHA classification II or III.
- Subject is willing and able to provide written consent.
Key exclusion criteria (17 listed)
- Subject has documented myocardial infarction before enrollment.
- Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.
- Subject has 2nd or 3rd degree AV block.
- Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).
- Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
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 |
|---|---|---|
| LBBAP TherapyCRT-D programmed for LBBAP (LV lead OFF) | Device | Sequence 1, Sequence 2 |
| LOT-CRTCRT-D programmed for LOT-CRT (LBBAP + LV lead ON) | Device | Sequence 1, Sequence 2 |
| ICDICD programmed for LBBAP | Device | Observational Treatment Arm |
| LOT-CRTCRT-D programmed for LOT-CRT (LBBAP + LV lead ON) | Device | Observational Treatment Arm |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: Baseline, 6 months, 12 months
Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
Left ventricular end-systolic volume (LVESV)
Time frame: Baseline, 6 months, 12 months
Change in LVESV assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
2 secondary outcomes
Left ventricular ejection fraction (LVEF)
Time frame: Baseline, 6 months
Left ventricular end-systolic volume (LVESV)
Time frame: Baseline, 6 months
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 20 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LBBAP Therapy, LOT-CRT and ICD in people with Heart Failure and Systolic Bundle Branch Block, Left, run by Medtronic Cardiac Rhythm and Heart Failure 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 8 inclusion and 17 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 20 Oct 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 Robert Stadler (763-526-0261, robert.stadler@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: Baseline, 6 months, 12 months). 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 20 Oct 2026.