RECRUITING

Concomitant LAAC/AF Ablation (Watchman FLX Pro)

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Conditions

PFA Ablation and LAAC ProceduresAF ablationFARADRIVE™Watchman FLX Pro

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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 sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).

Official Title

Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)

Quick Facts

Study Start:2025-06-01
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07041125

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:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who are determined by physicians to be eligible for LAAC
  2. * Patients whose LAAC with Watchman FLX Pro procedures are performed concomitant following AF ablation procedure
  3. * Willing and able to provide additional informed consent to the sub-study (unless waiver of consent is obtained)
  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

samantha S seepersad
CONTACT
3525720027
sseepersad@hrcrs.com

Study Locations (Sites)

Arrhythmia Center of South Florida
Delray Beach, Florida, 33484
United States
Ascension St. Vincent's Jacksonville
Jacksonville, Florida, 32204
United States
HCA Research Institute- Mercy Hospital
Miami, Florida, 37203
United States
Ascension St Vincent -Indianapolis Ascension Health
Indianapolis, Indiana, 46184
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
United States

Collaborators and Investigators

Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

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 Date2025-06-01
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2025-06-01
Study Completion Date2026-10-30

Terms related to this study

Keywords Provided by Researchers

  • AF ablation
  • FARADRIVE™
  • Watchman FLX Pro

Additional Relevant MeSH Terms

  • PFA Ablation and LAAC Procedures