RECRUITING

Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)

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

The goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients with pre-existing left bundle branch area pacemakers (LBBAP) programmed to an atrial sensing mode. Measurements of right ventricular, left ventricular function, and exercise capacity will be obtained at various LBBAP programming parameters at rest and during low intensity exercise. The main aims of the study are: * Demonstrate the safety and feasibility of performing CPET-CMR in patients with pre-existing LBBAP programmed to P-synchronous ventricular pacing mode. * Generate preliminary data evaluating differences in RV function, LV function, and exercise capacity during various pacemaker programming settings.

Official Title

Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)

Quick Facts

Study Start:2024-08-23
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06601322

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. * presence of dual chamber LBBAP implantation
  2. * presence of anodal capture with bipolar pacing configuration as determined at pacing implant.
  1. * Known history of chronotropic incompetence
  2. * high degree or complete heart block
  3. * inability to tolerate NVP during initial device interrogation
  4. * pregnancy
  5. * inability to undergo MRI or exercise utilizing supine bicycle at target work-load
  6. * presence of MRI unsafe pacemaker components.

Contacts and Locations

Study Contact

Ajay Pillai
CONTACT
(478) 957-2109
ajay.pillai@vcuhealth.org
Melissa Sears
CONTACT
804-828-1601
melissa.sears@vcuhealth.org

Principal Investigator

Ajay Pillai
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Ajay Pillai, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

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 Date2024-08-23
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-08-23
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Pacemaker
  • CPET-CMR

Additional Relevant MeSH Terms

  • Left Branch Bundle Block
  • RV - Right Ventricular Abnormality