Pacing Methods for Heart Failure

(SYNCHRONICITY Trial)

Recruiting at 1 trial location

Overseen By Jacqueline Beaulieu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Ace inhibitors, Beta blockers

Disqualifiers: Atrial fibrillation, Pacemaker, Heart transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to assist people with heart failure by pacing their hearts. One method, Cardiac Resynchronization Therapy (CRT), uses a device to enhance heart pumping. The other method, Left Bundle Branch Area Pacing (LBBAP), is under evaluation to determine if it performs as well or better. Suitable candidates for this trial include those with heart failure, a specific heart rhythm issue known as left bundle branch block, and those already on certain heart medications. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance heart failure treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on certain heart failure medications for at least 3 months before joining. It's best to discuss your specific medications with the trial team.

What prior data suggests that these pacing methods are safe for heart failure treatment?

Research has shown that Left Bundle Branch Area Pacing (LBBAP) could benefit people with heart failure. Studies suggest this method might reduce hospital visits for heart failure and lower the risk of death compared to other pacing methods. Although the FDA has approved LBBAP for heart use, it is not specifically approved for treating heart failure. This approval indicates a certain level of safety for heart pacing.

While LBBAP is generally well-tolerated, individual experiences can vary, and some people might still experience side effects. It is crucial to consult a healthcare provider to understand the potential risks and benefits for each specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pacing Methods for Heart Failure trial because it explores Left Bundle Branch Area (LBBA) pacing, a novel approach that could offer significant advantages over standard cardiac resynchronization therapy (CRT). Unlike traditional CRT, which uses a quadripolar lead to stimulate the heart, LBBA pacing aims to more naturally synchronize the heart's electrical activity by targeting the specific area responsible for conducting electrical impulses. This method may improve heart function more effectively and reduce complications associated with conventional pacing. By potentially offering a more physiological approach to heart failure treatment, LBBA pacing could enhance patient outcomes and quality of life.

What evidence suggests that these pacing methods are effective for heart failure?

Research has shown that Left Bundle Branch Area Pacing (LBBAP), which participants in this trial may receive, is a promising treatment for heart failure. Studies have found that LBBAP improves heart function by enhancing the timing of its electrical signals. Compared to traditional methods, patients with LBBAP have experienced better heart pumping and overall heart health. It is also considered safe and effective in correcting heart rhythm issues. These findings suggest LBBAP could be a good option for heart failure patients seeking better results. Meanwhile, another group in this trial will receive a CRT-D device using a Quadripolar lead, serving as an active comparator to evaluate the effectiveness of LBBAP. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who haven't improved after at least 3 months on full heart failure medication. They must need an ICD (implantable cardioverter-defibrillator), have a weak pumping chamber of the heart, and specific electrical delays in their heartbeat. Participants should be willing to use remote monitoring, give informed consent, stay local for follow-ups, and not have conditions that exclude them.

Inclusion Criteria

Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1, V2, V5, V6) within 3 months of enrollment

Patient is willing to participate in LATITUDE™ NXT remote patient monitoring

Patient plans to remain geographically stable (not permanently moving to another location) and can commit to all study participation requirements (procedure, follow-up visits and testing requirements)

Exclusion Criteria

History of heart transplantation or left ventricular assist device (LVAD) implantation

Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment

Current or prior pacemaker, ICD or CRT implant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized and implanted with either a BSC CRT-D using the INGEVITY+ pace/sense lead in the LBBA or a Quadripolar lead for CRT.

12 months

Regular visits for device monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness, including system-related complication-free rate and composite endpoints.

Up to 5 years

Annual visits for comprehensive assessment

What Are the Treatments Tested in This Trial?

Interventions

• Left Bundle Branch Area Pacing

Trial Overview The study compares two pacing methods for treating heart failure: conventional Cardiac Resynchronization Therapy (CRT) using a lead in a vein on the left ventricle's surface versus Left Bundle Branch Area Pacing (LBBAP) where the lead is placed directly in the Left Bundle Branch Area.

How Is the Trial Designed?

Group I: LBBA Cohort Experimental Treatment 1 Intervention

Participants will be randomized, implanted with a BSC CRT-D using the INGEVITY+ pace/sense lead implanted in the LBBA, and device programmed to the respective cohort.

Group II: CRT Cohort Active Control 1 Intervention

Participants will be randomized, implanted with a BSC CRT-D device using a Quadripolar lead, and device programmed to the respective cohort.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. academic.oup.com academic.oup.com/europace/article/27/8/euaf181/8242754

Two-year outcomes of left bundle branch area pacing versus ... This registry-based trial compared left bundle branch area pacing (LBBAP) with RVP in patients younger than 65 years. Methods and results. Using ...

2. hrsonline.org hrsonline.org/news/lcbt-showcase-promising-outcomes-left-bundle-branch-area-pacing/

Late-Breaking Clinical Trials at Heart Rhythm 2025 ... Findings from two late-breaking clinical trials demonstrate the safety and efficacy of left bundle branch area pacing (LBBAP), adding to the growing body of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38812213/

Left bundle branch area pacing in heart failure LBBAP was associated with improved ventricular electrical synchrony compared to BVP, as well as better echocardiographic and clinical outcomes.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527125024580

Outcomes of left bundle branch area pacing upgrade in ... LBBAP is a safe and effective strategy for treating PICM, providing significant reversal of electrical and mechanical dyssynchrony and improvement in ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)00242-X/fulltext

Comparisons of long-term clinical outcomes with left ... Left bundle branch area pacing (LBBAP) can also maintain and improve left ventricular (LV) electromechanical synchrony by left bundle branch ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.072414?doi=10.1161/CIRCULATIONAHA.124.072414

Left Bundle Branch Pacing: State of the Art and Future ... Thus, LBBP shows promise in patients with LBBB and heart failure, including (1) nonischemic cardiomyopathy with correctable LBBB and moderate ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07069738

NCT07069738 | Safety and Effectiveness of Left Bundle ... This study will compare two different methods to pace the heart to treat heart failure including: The current standard method of implanting a pacing lead in ...