ACTIVE_NOT_RECRUITING

ADVENT Post Approval Study

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Conditions

Paroxysmal Atrial FibrillationPulsed Field AblationPFAPulmonary Vein IsolationPVIAblationAtrial FibrillationAF

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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

The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.

Official Title

Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

Quick Facts

Study Start:2024-09-25
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06431815

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. * Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
  2. * Subjects who are willing and capable of providing informed consent;
  3. * Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;
  4. * Subjects who are of legal age to give informed consent specific to the national law.
  5. * For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
  1. * Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);
  2. * Subjects with any prior left atrium (LA) ablation;
  3. * Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);
  4. * Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);
  5. * Life expectancy of \< 1 year, per investigator's medical judgement.

Contacts and Locations

Principal Investigator

Stavros E Mountantonakis, MD, MBA
PRINCIPAL_INVESTIGATOR
Northwell Health, Lenox Hill Hospital

Study Locations (Sites)

Mobile Infirmary Medical Center
Mobile, Alabama, 36608
United States
Scottsdale Healthcare - Shea
Scottsdale, Arizona, 85258
United States
Alta Bates Summit Medical Center
Oakland, California, 94609
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale, Florida, 33308
United States
Baptist Medical Center
Jacksonville, Florida, 32207
United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140
United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
United States
AdventHealth Tampa
Tampa, Florida, 33613
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4504
United States
New York Hospital Queens
Flushing, New York, 11355
United States
Columbia University Medical Center
New York, New York, 10019
United States
Northwell Health
New York, New York, 10075
United States
Montefiore Medical Center
The Bronx, New York, 10461
United States
East Carolina University Medical Center
Greenville, North Carolina, 27834
United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, 17104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0737
United States
University of Texas Houston Health Science Center
Houston, Texas, 77030
United States
Orion Medical
Houston, Texas, 77034
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

  • Stavros E Mountantonakis, MD, MBA, PRINCIPAL_INVESTIGATOR, Northwell Health, Lenox Hill Hospital

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 Date2024-09-25
Study Completion Date2029-10

Study Record Updates

Study Start Date2024-09-25
Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

  • Pulsed Field Ablation
  • PFA
  • Pulmonary Vein Isolation
  • PVI
  • Ablation
  • Atrial Fibrillation
  • AF

Additional Relevant MeSH Terms

  • Paroxysmal Atrial Fibrillation