RECRUITING

Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System

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

STAR Apollo Mapping System is an FDA cleared mapping technology that can analyze the signals collected during the ablation procedure on the 3D mapping system and give the physician further insight into the AF activation patterns which may assist them in identifying areas responsible for maintaining Atrial Fibrillation (AF). The STAR Apollo Mapping System system allows clinicians, after treating the Pulmonary Veins (PV), to collect data from the atria during clinical AF procedures using standard FDA cleared catheters and devices. This study aims to examine the impact of the STAR Apollo Mapping System on procedural and acute outcomes in a multicenter observational study.

Official Title

Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System

Quick Facts

Study Start:2023-10-02
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05826665

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 to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Indication for ablation of persistent AF
  2. * Age \>18 years
  3. * Persistent AF \>7 days and total continuous duration \<2 years
  4. * Patients have previously undergone pulmonary vein isolation, using any technique and have had AF recurrence.
  5. * Patients have limited additional ablation at their first procedure (e.g. right atrial flutter line).
  1. * Patients with previous ablation in more than one region of the left atrium in addition to the pulmonary veins.
  2. * Patients with longstanding persistent AF (continuous duration \>2 years) or significant substrate (mitral valve disease, scarring, very dilated atria \>50mm).
  3. * Creatinine clearance estimated glomerular filtration rate (eGFR) \<30mls/min
  4. * Contraindication to anticoagulation

Contacts and Locations

Study Contact

Donita Atkins
CONTACT
816-651-1969
datkins@kchrf.com

Principal Investigator

Dhanunjaya Lakkireddy, MD
PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute

Study Locations (Sites)

St.Bernards Medical Center
Jonesboro, Arkansas, 72401
United States
Sarasota Medical Center
Sarasota, Florida, 34239
United States
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
United States

Collaborators and Investigators

Sponsor: Kansas City Heart Rhythm Research Foundation

  • Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

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 Date2023-10-02
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Persistent Atrial Fibrillation