RECRUITING

AVEIR DR Coverage With Evidence Development (CED) 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

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Official Title

The AVEIR DR Coverage With Evidence Development (DRIVE) Study

Quick Facts

Study Start:2023-10-31
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05932602

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. * Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nicole Harbert
CONTACT
972-526-4841
nicole.harbert@abbott.com
Stephanie Delgado
CONTACT
818-493-3285
stephanie.delgado1@abbott.com

Principal Investigator

Nicole Harbert
STUDY_DIRECTOR
Abbott

Study Locations (Sites)

Abbott
Sylmar, California, 91342
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Nicole Harbert, STUDY_DIRECTOR, Abbott

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 Date2023-10-31
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • dual chamber
  • sick sinus rhythm
  • pacemaker
  • AV Block

Additional Relevant MeSH Terms

  • Cardiac Pacemaker
  • Arrythmia
  • Bradycardia