Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04239534
Status:
WITHDRAWN
Last Update Posted:
2022-07-27
First Post:
2020-01-13
Brief Title:
CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF
Sponsor:
AtriCure Inc
Organization:
AtriCure Inc
Study Overview
Official Title:
Continued Access Protocol For Convergence Of Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Persistent AF CONVERGE CAP Study
Status:
WITHDRAWN
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Start-up and enrolling activities have been suspended and study closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP
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 andor 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 sites standard of care SOC needed to complete the subjects 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 subjects 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 IRBEC 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 subjects 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
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 sites standard of care SOC needed to complete the subjects 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 subjects 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 IRBEC 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None