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CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF (CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239534
Recruitment Status : Suspended (Start-up and enrolling activities have been temporatily suspended due to the COVID-19 pandemic.)
First Posted : January 27, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Brief Summary:
The objective of this clinical study is to collect additional data on the safety and effectiveness of the EPi- Sense®-AF Guided Coagulation System with VisiTrax® to treat symptomatic persistent or long-standing persistent Atrial Fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Convergence Of Epicardial And Endocardial RF Ablation Not Applicable

Detailed Description:

This is a prospective CAP, multi-center, single arm study. The study will enroll one hundred and seventy subjects (170) to ensure that 153 subjects are treated with the EPi-Sense®-AF device, after accounting for post-enrollment subject ineligibility. Patients will be enrolled from up to twenty-seven (27) sites that enrolled patients in the CONVERGE study. For consistency, the same endpoints defined in the CONVERGE study will be used in the CAP.

The population for this study will be subjects with Persistent or Long-standing Persistent atrial fibrillation defined in accordance with the Heart Rhythm Society (HRS) 2017 AF expert consensus statement.

  • Persistent: Continuous AF which is sustained beyond seven days.
  • Long-standing Persistent: Continuous AF of greater than 12 months' duration. Subject informed consent might be obtained in two phases to allow for additional testing, beyond the site's standard of care (SOC) needed to complete the subject's eligibility to participate in this trial. If additional tests are needed to determine study eligibility, the subjects will sign a Screening ICF. Following a full evaluation, if it is determined that the subject is eligible to participate in the CONVERGE CAP study, the subject will sign an Enrollment ICF. Sites will continue to monitor subjects implanted with a loop recorder who did not qualify to be enrolled in the study. If the ILR indicates a change in the subject's AF status from paroxysmal to persistent AF and the subject continues to meet study eligibility criteria, the subject could sign an Enrollment consent to participate in the study.

Subjects will be provided the IRB/EC approved ICFs (Screening and Enrollment) and will have the opportunity to read, understand, and have their questions answered prior to signing the ICFs. If the subject agrees to participate in the study and signs consent, the ICF process will be completed. The subject must sign and date the Screening ICF prior to any additional assessments needed to determine study eligibility and sign and date the Enrollment ICF prior to study-specific procedures being performed. The person reviewing the ICF with the subject will also sign and date the ICFs. The subject will be given copies of the signed ICFs to keep. The Screening ICF will be required only if non-study evaluations are needed to determine the subject's eligibility to participate in the study.

Upon entering subject enrollment information into Clindex, each subject will be assigned a unique identification (ID) number sequentially in ascending order. All subjects who sign the ICFs will be documented in a Screening and Enrollment Log. For subjects who sign the Screening ICF but are ineligible to participate, minimum baseline characteristics: age, gender, race, screening date and screen failure reason (s) will be captured in Clindex.

Subjects are considered to be enrolled in the study when they have signed the Enrollment ICF. Subjects are considered to be treated when any of the study devices are introduced into the body.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Continued Access Protocol (CAP), prospective, multi-center, single arm study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continued Access Protocol For Convergence Of Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Persistent AF CONVERGE CAP Study
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single Arm
In this Single Arm Study, Epicardial linear lesions will be created endoscopically using the EPi-Sense-AF Guided Coagulation System with VisiTrax throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access. Followed by the sue of an endocardial ablation catheter that will be used to ablate endocardially to connect lesions at the reflections, complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter.
Device: Convergence Of Epicardial And Endocardial RF Ablation
The epicardial lesion pattern will be created using the EPi-Sense®-AF Guided Coagulation System with VisiTrax®. Epicardial linear lesions will be created endoscopically using the EPi-Sense-AF Guided Coagulation System with VisiTrax throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to ablate endocardially to connect lesions at the reflections, complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi- Sense-AF Guided Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation.




Primary Outcome Measures :
  1. Primary Effectiveness Endpoint- Freedom from Atrial Fibrillation, Atrial Tachycardia and Atrial Flutter [ Time Frame: From Three month blanking period until 12-months post procedure follow-up visit. ]

    The primary effectiveness endpoint is freedom from AF/AT/AFL absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-months blanking period through the 12-months post procedure follow-up visit.

    The primary effectiveness endpoint will be evaluated from the 24-hours Holter.


  2. Primary Safety Endpoint- Evaluation of major adverse events (MAEs) from the procedure to 30-days post procedure. [ Time Frame: From procedure to 30-days post procedure ]
    The primary safety endpoint for the study is the incidence of major adverse events (MAEs) for subjects undergoing the convergent procedure from the procedure to 30-days post procedure. The following MAEs occurring within 30 days of the procedure will contribute toward the primary safety endpoint: cardiac tamponade, severe pulmonary vein (PV) stenosis, excessive bleeding, myocardial infarction, Stroke, transient ischemic attacks (TIA), atrioesophageal fistula (AEF), phrenic nerve injury, and death.


Secondary Outcome Measures :
  1. Effectiveness-Freedom for Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter and reduction of Atrial Fibrillation burden [ Time Frame: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation ]
    1. Freedom from AF/AT/AFL > 30 seconds in duration in the absence class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-months blanking period through the 24- and 36- months post procedure follow-up visits.
    2. Freedom from AF/AT/AFL > 1 hour in duration in the absence of class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-months blanking period through the 24 and 36- months post procedure follow-up visits.

  2. Effectiveness- Atrial Fibrillation burden reduction [ Time Frame: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation ]
    1. Burden reduction of ≥75% and ≥90% from baseline AF burden and off all Class I and III AADs at 12, 24, and 36-months post procedure.
    2. Burden reduction of ≥75% and ≥90% from baseline AF burden regardless of Class I and III AAD status at 12, 24, and 36-months post procedure.

  3. Safety-Incidence of serious adverse events [ Time Frame: Through 12-months post procedure visit ]
    Incidence of serious adverse events (SAEs) in the study through the 12-months post procedure visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years and < 80 years at time of enrollment consent.
  2. Left atrium ≤ 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view) or equivalent test.
  3. Refractory or intolerant to at least one AAD (class I and/or III).
  4. Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines.
  5. Provided written informed consent.

Exclusion Criteria:

  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 < 40%.
  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 a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias).
  14. Patients with existing ICDs.
  15. 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.
  16. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
  17. Patient has presence of thrombus in the left atrium determined by intraoperative TEE.
  18. Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 % stenosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239534


Locations
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United States, Alabama
Grandview Medical Center
Birmingham, Alabama, United States, 35243
Heart Center Research LLC
Huntsville, Alabama, United States, 35801
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
St. Vincent's HealthCare
Jacksonville, Florida, United States, 32204
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States, 33410
United States, Georgia
Emory University - St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
United States, Mississippi
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
United States, Virginia
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23229
United Kingdom
St. Bartholomew's Hospital
London, United Kingdom, E1 1BB
Guy's and St. Thomas Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Principal Investigator: David De Lurgio, M.D. Emory University
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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT04239534    
Other Study ID Numbers: CP2019-1
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by AtriCure, Inc.:
Hybrid Procedure
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes