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Cardiac Resynchronization Therapy for Heart Failure

(ACHIEVED LBBAP Trial)

DK
RS
Overseen ByRobert Stadler
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are 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

Subject is willing and able to provide written 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
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Exclusion Criteria

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
Subject is implanted with a left ventricular assist device (LVAD)
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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

Group I: Sequence 2Experimental Treatment2 Interventions
Group II: Sequence 1Experimental Treatment2 Interventions
Group III: Observational Treatment ArmExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials
206
Recruited
137,000+
Geoff Martha profile image

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson profile image

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

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