An interventional study of Convergence Of Epicardial And Endocardial RF Ablation in Atrial Fibrillation, sponsored by AtriCure, Inc.. Withdrawn at 10 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by AtriCure, Inc. · Not applicable, Interventional, and Treatment
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.
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.
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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Exclusion Criteria:
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 Effectiveness Endpoint- Freedom from Atrial Fibrillation, Atrial Tachycardia and Atrial Flutter
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.
Time frame: From Three month blanking period until 12-months post procedure follow-up visit.
Primary Safety Endpoint- Evaluation of major adverse events (MAEs) from the 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.
Time frame: From procedure to 30-days post procedure
Effectiveness-Freedom for Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter and reduction of Atrial Fibrillation burden
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.
Time frame: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation
Effectiveness- Atrial Fibrillation burden reduction
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.
Time frame: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation
Safety-Incidence of serious adverse events
Incidence of serious adverse events (SAEs) in the study through the 12-months post procedure visit.
Time frame: Through 12-months post procedure visit
Plan to share: No
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AtriCure, Inc.