ACTIVE_NOT_RECRUITING

CONVERGE Post-Approval Study (PAS)

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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 primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Official Title

Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF

Quick Facts

Study Start:2022-04-13

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05393180

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 Criteria	Exclusion Criteria
1. Age ≥ 18 years and \< 80 years at time of enrollment consent; 2. Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography \[TTE\] with parasternal 4 chamber view or equivalent imaging modality; 3. Refractory or intolerant to at least one AAD (class I and/or III); 4. Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (\> 12 months of continuous AF); 5. Life expectancy \> 12 months; and 6. Provides written informed consent.	1. Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure; 2. Left ventricular ejection fraction \< 35%; 3. Pregnant or planning to become pregnant during study; 4. Co-morbid medical conditions that limit one-year life expectancy; 5. Previous cardiac surgery; 6. History of pericarditis; 7. Previous cerebrovascular accident (CVA), excluding fully resolved TIA; 8. Patients who have active infection or sepsis 9. Patients with esophageal ulcers strictures and varices; 10. Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40); 11. Patients who are contraindicated for anticoagulants such as heparin and coumadin; 12. Patients who are being treated for ventricular arrhythmias; 13. Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE: Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) and no other left atrial lesions; 14. Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment; 15. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative); 16. Patient has presence of thrombus in the left atrium determined by intraoperative TEE; 17. Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins \>50 % stenosis; 18. Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study; 19. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 20. Presence of Barretts esophagitis

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years and \< 80 years at time of enrollment consent;
2. Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography \[TTE\] with parasternal 4 chamber view or equivalent imaging modality;
3. Refractory or intolerant to at least one AAD (class I and/or III);
4. Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (\> 12 months of continuous AF);
5. Life expectancy \> 12 months; and
6. Provides written informed consent.

1. Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
2. Left ventricular ejection fraction \< 35%;
3. Pregnant or planning to become pregnant during study;
4. Co-morbid medical conditions that limit one-year life expectancy;
5. Previous cardiac surgery;
6. History of pericarditis;
7. Previous cerebrovascular accident (CVA), excluding fully resolved TIA;
8. Patients who have active infection or sepsis
9. Patients with esophageal ulcers strictures and varices;
10. Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40);
11. Patients who are contraindicated for anticoagulants such as heparin and coumadin;
12. Patients who are being treated for ventricular arrhythmias;
13. Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE: Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) and no other left atrial lesions;
14. Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment;
15. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative);
16. Patient has presence of thrombus in the left atrium determined by intraoperative TEE;
17. Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins \>50 % stenosis;
18. Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study;
19. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
20. Presence of Barretts esophagitis

Contacts and Locations

Study Locations (Sites)

Sutter Bay Hospitals

San Francisco, California, 94107

United States

Hartford Hospital

Hartford, Connecticut, 06102

United States

Baycare Health Systems

Clearwater, Florida, 33759

United States

Orlando Health

Orlando, Florida, 32806

United States

Emory Saint Joseph Hopsital

Atlanta, Georgia, 30322

United States

Wellstar Health System

Marietta, Georgia, 30062

United States

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218

United States

Southcoast Hospitals Group

New Bedford, Massachusetts, 02740

United States

AtlantiCare Medical Center

Atlantic City, New Jersey, 08401

United States

Avera Heart Hospital of SD

Sioux Falls, South Dakota, 57108

United States

University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: AtriCure, Inc.

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 Date2022-04-13

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2022-04-13

Study Completion Date2029-01-01

Terms related to this study

Additional Relevant MeSH Terms

Chronic Atrial Fibrillation