RECRUITING

The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.

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Conditions

Paroxysmal Atrial Fibrillation

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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

Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.

Official Title

The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO™ System Use in Conjunction With VISITAG SURPOINT™Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

Quick Facts

Study Start:2024-02-27
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06324201

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. 1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
  2. 2. 18 years of age or older
  3. 3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
  4. 4. Willing and able to provide informed consent for this sub-study
  1. 1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
  2. 2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
  3. 3. Persistent or long-standing persistent AF
  4. 4. In the opinion of the investigator, any known contraindication to an ablation procedure

Contacts and Locations

Study Contact

Jennifer Moss
CONTACT
615-448-5770
jmoss@hrcrs.com

Principal Investigator

Brian Sanchez, MD
STUDY_DIRECTOR
J & J Corporation

Study Locations (Sites)

Arrhythmia Institute at Grandview
Birmingham, Alabama, 35209
United States
Mobile Cardiology Associates
Mobile, Alabama, 36608
United States
Community Memorial Health System
Ventura, California, 93003
United States
Medical City - HCA
Aurora, Colorado, 80012
United States
Naples Community Hospital
Naples, Florida, 34102
United States
Sarasota Memorial Health
Sarasota, Florida, 34239
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205
United States
The Brigham and Womens Hospital
Boston, Massachusetts, 02115
United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
United States
Trinity Health-Michigan Heart
Ypsilanti, Michigan, 48197
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
University of Cincinnati
Cincinnati, Ohio, 45221
United States
University of Pennsylvania (UPENN)
Philadelphia, Pennsylvania, 19104
United States
Allegheny Health
Pittsburgh, Pennsylvania, 15212
United States
Centra Health, Inc.dba Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
United States
Bon Secours Medical Group - Richmond Specialty Care
Richmond, Virginia, 23226
United States
Valley Health System
Winchester, Virginia, 22601
United States
Multicare Health Systems-Pulse Heart
Puyallup, Washington, 98372
United States
Franciscan Heart and Vascular Associates
Tacoma, Washington, 98401
United States
Mercy Health
Janesville, Wisconsin, 53548
United States

Collaborators and Investigators

Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

  • Brian Sanchez, MD, STUDY_DIRECTOR, J & J 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 Date2024-02-27
Study Completion Date2028-03

Study Record Updates

Study Start Date2024-02-27
Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

  • Paroxysmal Atrial Fibrillation