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NCT Number: NCT05869500

The Boston Pace Study

Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction. However, implantation of coronary sinus lead increases procedural risk and can be limited by higher threshold and phrenic nerve capture. HIS pacing has been evaluated as an alternative pacing strategy, but its routine use was limited by difficulty of the procedure, success rate and high pacing threshold.

Left bundle branch area pacing (LBBAP) is a promising physiologic pacing technique that has been proposed as a pacing strategy to prevent pacing induced cardiomyopathy and for treatment of desynchrony in heart failure. LBBAP has been adopted widely and performed routinely on patients with AV block. Currently, it is up to the discretion of the proceduralist whether LBBAP is performed given that there is lack of evidence to guide pacing strategies.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Left Bundle Branch Area Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

This pilot trial is a feasibility study that will assess for efficacy, safety and success rate of left bundle branch area pacing. The study will also examine the recruitment rate at 2 major tertiary hospitals.

The study will examine if the use of LBBAP can prevent the occurrence of pacing induced cardiomyopathy (PICM) compared to RV pacing among patients with normal left ventricular function and high-grade AV block.

The investigators hypothesize that the rate of pacing induced cardiomyopathy is lower with LBBAP compared to RV pacing in patients with normal left ventricular function requiring high burden of RV pacing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18
  • Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40%
  • Left ventricular ejection fraction of 50% or more.
  • Echocardiogram within the last 3 months

Exclusion criteria

  • History of systolic dysfunction with LV EF of less than 50%
  • Prior myocardial infarction
  • Obstructive coronary artery disease
  • Severe valvular dysfunction
  • Life expectancy of less than a year
  • Pregnancy

Treatment and study plan

Left Bundle Branch Area Pacemaker

Device

Implantation of Medtronic 3830 lead for left bundle branch area pacing

Right Ventricular Pacemaker

Device

Implantation of a conventional right ventricular pacemaker lead

Primary outcomes

  1. Change in left ventricular ejection fraction (LVEF)

    Time frame: 12 months

  2. Change in left ventricular end systolic volume (LVESV)

    Time frame: 12 months

Secondary outcomes

  1. Success rate of LBBAP

    Time frame: 30 days

  2. All-cause mortality

    Time frame: 12 months

  3. Cardiovascular mortality

    Time frame: 12 months

  4. Rate of heart failure related visit: defined as heart failure hospitalization or emergency room visit or urgent visit requiring intravenous heart failure therapy

    Time frame: 12 months

  5. Number of participants with upgrade to cardiac resynchronization therapy

    Time frame: 12 months

  6. New York Heart Association Class I-IV (IV is worst)

    Time frame: 12 months

  7. Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram

    Time frame: 12 months

  8. Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram

    Time frame: 12 months

  9. Number of participants with new onset atrial fibrillation

    Time frame: 12 months

  10. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)

    Time frame: 12 months

  11. Paced QRS duration on 12 lead EKG

    Time frame: Evaluated at 1 day, 30 days and 12 months

  12. Pacing percentage

    Time frame: 12 months

  13. Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision

    Time frame: 12 months

  14. Procedure time

    Time frame: 1 day

  15. Fluoroscopy time

    Time frame: 1 day

  16. Pacing capture threshold (V)

    Time frame: 12 months

  17. R wave amplitude (mV)

    Time frame: 12 months

  18. RV lead impedance (ohms)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Medtronic

Registry information

Official study title

Left Bundle Area Pacing Vs. Right Ventricular Pacing in Patients With Normal Left Ventricular Function -The Boston Pace Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 22, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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