ACTIVE_NOT_RECRUITING

REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry

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

This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation.

Official Title

REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-study of the REAL AF Registry

Quick Facts

Study Start:2024-04-03
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06354777

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. * Symptomatic Paroxysmal Atrial Fibrillation (AF episode terminate spontaneously within 7 days) or Persistent Atrial Fibrillation (AF sustained beyond 7 days) who, in the opinion of the investigator, are scheduled for ablation for Atrial Fibrillation with active esophageal cooling.
  2. * \>18 years of age
  3. * Index or redo ablation procedure and enrolled in the REAL AF Registry
  4. * Willing and able to provide informed consent and complete GERD questionnaire.
  1. * For the purpose of this sub-study, candidates will be excluded if they meet any of the following criteria:
  2. * Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
  3. * In the opinion of the investigator, any known contraindication to an ablation procedure.
  4. * \<18 years of age

Contacts and Locations

Principal Investigator

Carla G Perna, MPH
STUDY_DIRECTOR
Heart Rhythm Clinical and Research Solutions, LLC
Tiffany Sharkoski, MPH
STUDY_CHAIR
Haemonetics Corporation

Study Locations (Sites)

Valley Heart Rhythm Specialists
Chandler, Arizona, 85224
United States
Ascension St. Vincent Hospital Indianapolis
Indianapolis, Indiana, 46260
United States
Corewell Health Research Institute
Royal Oak, Michigan, 48067
United States
Christ Hospital
Cincinnati, Ohio, 45219
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98001
United States

Collaborators and Investigators

Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

  • Carla G Perna, MPH, STUDY_DIRECTOR, Heart Rhythm Clinical and Research Solutions, LLC
  • Tiffany Sharkoski, MPH, STUDY_CHAIR, Haemonetics Corporation

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 Date2024-04-03
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2024-04-03
Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation