RECRUITING

The Boston Pace Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-01
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05869500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>18
  2. 2. Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40%
  3. 3. Left ventricular ejection fraction of 50% or more.
  4. 4. Echocardiogram within the last 3 months
  1. 1. History of systolic dysfunction with LV EF of less than 50%
  2. 2. Prior myocardial infarction
  3. 3. Obstructive coronary artery disease
  4. 4. Severe valvular dysfunction
  5. 5. Life expectancy of less than a year
  6. 6. Pregnancy

Contacts and Locations

Study Contact

Chee Yuan Ng, MD
CONTACT
617-724-4500
cyng1@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • left bundle branch
  • left bundle

Additional Relevant MeSH Terms

  • Left Bundle Branch Area Pacing