Clinical trial NCT04239534: CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF
Official title: Continued Access Protocol For Convergence Of Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Persistent AF CONVERGE CAP Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Hybrid Procedure
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Continued Access Protocol (CAP), prospective, multi-center, single arm study.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Primary Effectiveness Endpoint- Freedom from Atrial Fibrillation, Atrial Tachycardia and Atrial Flutter
timeFrame: From Three month blanking period until 12-months post procedure follow-up visit.
measure: Primary Safety Endpoint- Evaluation of major adverse events (MAEs) from the procedure to 30-days post procedure.
timeFrame: From procedure to 30-days post procedure
Secondary outcomes:
measure: Effectiveness-Freedom for Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter and reduction of Atrial Fibrillation burden
timeFrame: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation
measure: Effectiveness- Atrial Fibrillation burden reduction
timeFrame: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation
measure: Safety-Incidence of serious adverse events
timeFrame: Through 12-months post procedure visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research LLC
state: Alabama
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: St. Vincent's HealthCare
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University - St. Joseph's Hospital
state: Georgia
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas Hospital
Study officials:
affiliation: Emory University
name: David De Lurgio, M.D.
role: PRINCIPAL_INVESTIGATOR
References: