Cardiac Resynchronization Therapy for Heart Failure
(ACHIEVED LBBAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a new heart treatment for individuals with heart failure and Left Bundle Branch Block (LBBB). It compares two therapies: one uses a device to synchronize heartbeats, and the other optimizes this synchronization. Participants will try each therapy for six months to determine which better improves heart function and quality of life. Suitable candidates have been diagnosed with heart failure, experience symptoms that limit daily activities, and have LBBB. As an unphased trial, this study allows participants to contribute to important research that could enhance future heart treatments.
What prior data suggests that this cardiac resynchronization therapy is safe for heart failure patients?
Research has shown that Left Bundle Branch Area Pacing (LBBAP) safely treats heart failure. Studies have found that it reduces hospital visits for heart failure without raising the risk of death, indicating good patient tolerance.
Early results suggest that Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) is also safe and effective. LOT-CRT seems to enhance heart function more than some other methods, promoting more efficient heartbeats.
Overall, past research has demonstrated good safety for both treatments, making them promising options for people with heart failure.12345Why are researchers excited about this trial?
Researchers are excited about Left Bundle Branch Area Pacing (LBBAP) therapy and Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) because they offer a more precise approach to treating heart failure compared to traditional cardiac resynchronization therapy (CRT). Unlike standard CRT, which uses multiple leads to stimulate the heart ventricles, LBBAP directly targets the heart's left bundle branch, potentially providing more natural and efficient heart muscle contractions. LOT-CRT further optimizes this approach by fine-tuning the timing of electrical stimulation. These innovations may lead to improved heart function, better patient outcomes, and could reduce the need for more invasive interventions.
What evidence suggests that this trial's treatments could be effective for heart failure?
This trial will compare different cardiac resynchronization therapies for heart failure. Research has shown that Left Bundle Branch Area Pacing (LBBAP) therapy, which participants in this trial may receive, can enhance heart function. Patients who received this treatment showed a noticeable improvement in their heart's ability to pump blood. LBBAP also correlates with fewer hospital visits for heart failure and a lower risk of death from any cause.
Another treatment option in this trial is Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT), which combines LBBAP with another method to further boost heart function. Studies have found that LOT-CRT improves the heart's pumping ability and structure even more than LBBAP alone. Overall, both treatments show promise for improving heart function and reducing complications for patients needing heart rhythm support.678910Are You a Good Fit for This Trial?
This trial is for adults (18+) with heart failure and a specific type of electrical problem in the heart called left bundle branch block. Participants must have poor heart pumping function, moderate symptoms, and be eligible for a special defibrillator device. They need to be able to attend follow-up visits and give consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo LBBAP therapy for 6 months followed by LOT-CRT for 6 months, or vice versa, in a 2x2 randomized crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment, including echocardiographic assessments and quality of life evaluations
What Are the Treatments Tested in This Trial?
Interventions
- Implantable Cardioverter Defibrillator (ICD)
- Left Bundle Branch Area Pacing (LBBAP) Therapy
- Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT)
Trial Overview
The study compares two ways of using pacemakers/defibrillators: one uses pacing at the left bundle branch area alone, while the other adds an extra lead to further improve heart coordination (LOT-CRT). Each participant tries both methods over separate 6-month periods.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
LOT-CRT for 6 months followed by LBBAP therapy for 6 months
LBBAP therapy for 6 months followed by LOT-CRT for 6 months
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiac Rhythm and Heart Failure
Lead Sponsor
Geoff Martha
Medtronic Cardiac Rhythm and Heart Failure
Chief Executive Officer since 2020
MBA from University of Minnesota
Dr. Kweli Thompson
Medtronic Cardiac Rhythm and Heart Failure
Chief Medical Officer since 2022
MD from Harvard Medical School
Citations
Left bundle branch area pacing vs biventricular pacing for ...
Pooled results showed a significant improvement in LVEF among patients undergoing LBBAP as compared with BiVP (SMD 0.40, 95% CI 0.25 to 0.54, P ...
The Emerging Role of Left Bundle Branch Area Pacing ... - PMC
Overall, LBBAP appears to be associated with a significant reduction in the composite outcome of HF-related hospitalisation and all-cause mortality. LBBAP ...
3.
innovationsincrm.com
innovationsincrm.com/cardiac-rhythm-management/articles-2024/may/2213-clinical-and-electrophysiological-outcomes-of-left-bundle-area-pacing-compared-to-biventricular-pacingClinical and Electrophysiological Outcomes of Left Bundle ...
Our findings suggest that LBBAP may be a superior alternative to standard BVP in improving the structural, electrophysiological, and clinical components of ...
4.
acc.org
acc.org/latest-in-cardiology/journal-scans/2023/07/10/16/14/comparison-of-left-bundle-branchLeft Bundle Branch Area vs. Biventricular Pacing for CRT ...
LBBAP improved clinical outcomes when compared to BVP in patients with CRT indications and may be a reasonable alternative to BVP.
Comparative Outcomes of Left Bundle Branch Pacing and ...
Results: LBBaP achieved greater electrical resynchronization, with shorter postprocedural QRS duration (144 vs. 153 ms; p = 0.005) and shorter ...
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