Heart Failure NYHA Ii Iv / CRT-D with INGEVITY+ pace/sense lead / CRT-D with a Quadripolar LV lead · Interventional Study

Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an ongoing interventional device trial comparing left bundle branch area pacing (LBBAP) with conventional cardiac resynchronization therapy (CRT-D) in heart failure patients (NYHA II–IV). No results are posted; the study is currently recruiting and planned to follow participants for up to 5 years to assess mortality, transplant, LVAD use, heart failure events, and arrhythmia outcomes.

What was studied

Interventional, Randomized, Parallel, Single masking, Treatment purpose. Heart Failure - NYHA II - IV; age from 18 Years. Intervention: LBBA Cohort. Compared with: CRT Cohort — Active Comparator. n = 850. 40 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This trial addresses whether LBBAP, currently approved by the FDA only for standard pacing, may offer equivalent or superior safety and effectiveness compared to conventional CRT-D for heart failure treatment. Results when reported could inform device selection and implantation strategy in eligible heart failure patients.

Plain-language summary

This is a clinical trial registration with no posted results; it describes a planned interventional study comparing two pacing approaches in heart failure with an estimated enrollment of 850 and up to 5 years follow-up, but outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring d… (assessed at Through study completion, up to maximum of 5 years); System-related complication-free rate (assessed at 12 months)

DesignInterventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationHeart Failure - NYHA II - IV; age from 18 Years

Sample size850

InterventionLBBA Cohort

ComparatorCRT Cohort — Active Comparator

Setting40 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment850

Maximum follow-up duration5 years

System-related complication-free rate assessment timepoint12 months

Primary composite outcome assessment timepointThrough study completion, up to maximum of 5 years

Clinical bottom line

Caveats

This is a registry record with no results posted; all outcome data are pending study completion.
Randomization method, blinding, and control of bias are not described in the registry record.
Effect sizes, hazard ratios, and statistical significance cannot be assessed because the trial has not reported results.
LBBAP for heart failure treatment remains investigational; generalizability will depend on final trial outcomes and regulatory decisions.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional device comparison study; phase and randomization details not specified in registry record.

Directness

strong

Primary outcomes include hard endpoints: all-cause mortality, transplant, LVAD, and arrhythmia therapy.

Consistency

insufficient

Registry record only; no results posted to allow consistency assessment.

Risk of bias

insufficient

Randomization, blinding, and allocation concealment not described in registry record.

Sample adequacy

strong

Planned enrollment of 850 participants with up to 5 years maximum follow-up.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07069738). This is a study registration, not published results. Lead sponsor: Boston Scientific Corporation. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 850 participants (ESTIMATED). Conditions: Heart Failure - NYHA II - IV. Interventions: DEVICE: CRT-D with a Quadripolar LV lead; DEVICE: CRT-D with INGEVITY+ pace/sense lead. Primary outcome measures: Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion. , Through study completion, up to maximum of 5 years; System-related complication-free rate , 12 months. Brief summary: This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Heart Failure NYHA Ii IvCRT-D with INGEVITY+ pace/sense leadBoston ScientificCRT-D with a Quadripolar LV leadNCT07069738