Atrial FibrillationCAPNCT04239534
CONVERGE CAP Study-For The Treatment Of Symptomatic Persistent or Long-standing Persistent AF
A study testing Convergence Of Epicardial And Endocardial RF Ablation in people with Atrial Fibrillation, run by AtriCure, Inc. at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Convergence Of Epicardial And Endocardial RF Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Dec 2021to Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and < 80 years at time of enrollment consent.
- Left atrium ≤ 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view) or equivalent test.
- Refractory or intolerant to at least one AAD (class I and/or III).
- Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines.
- Provided written informed consent.
Who cannot join
- Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure.
- Left ventricular ejection fraction < 40%.
- Pregnant or planning to become pregnant during study.
- Co-morbid medical conditions that limit one-year life expectancy.
- Previous cardiac surgery.
- History of pericarditis.
Show all 18Show fewer
- Previous cerebrovascular accident (CVA), excluding fully resolved TIA.
- Patients who have active infection or sepsis.
- Patients with esophageal ulcers strictures and varices.
- Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40).
- Patients who are contraindicated for anticoagulants such as heparin and coumadin.
- Patients who are being treated for ventricular arrhythmias.
- Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias).
- Patients with existing ICDs.
- 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.
- Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
- Patient has presence of thrombus in the left atrium determined by intraoperative TEE.
- Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 % stenosis.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Emory University - St. Joseph's Hospital
Atlanta, Georgia, 30342
Grandview Medical Center
Birmingham, Alabama, 35243
Heart Center Research LLC
Huntsville, Alabama, 35801
St. Vincent's HealthCare
Jacksonville, Florida, 32204
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, 33410
Virginia Cardiovascular Specialists
Richmond, Virginia, 23229
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United Kingdom2 sites
St. Bartholomew's Hospital
London, E1 1BB
Guy's and St. Thomas Hospital
London, SE1 7EH
About this study
Official title: Continued Access Protocol For Convergence Of Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Persistent AF CONVERGE CAP Study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Convergence Of Epicardial And Endocardial RF Ablation
- Keywords
- Hybrid Procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convergence Of Epicardial And Endocardial RF AblationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | 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. Receives: Device: Convergence Of Epicardial And Endocardial RF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From procedure to 30-days post procedure
Secondary outcomes (3)
Effectiveness-Freedom for Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter and reduction of Atrial Fibrillation burden
- 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.
- 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.
Measured: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation
Effectiveness- Atrial Fibrillation burden reduction
- 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.
- 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.
Measured: 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.
Measured: Through 12-months post procedure visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: Start-up and enrolling activities have been suspended and study closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Continued Access Protocol (CAP), prospective, multi-center, single arm study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David De Lurgio, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239534
- Sponsor's protocol ID
- CP2019-1
- Acronym
- CAP
- Status last verified
- Aug 2021
- First submitted
- 13 Jan 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Access Protocol For Convergence Of Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Persistent AF CONVERGE CAP Study
- ClinicalTrials.gov ID
- NCT04239534
- Acronym / sponsor ID
- CAP / CP2019-1
- Conditions
- Atrial Fibrillation
- Keywords
- Hybrid Procedure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Start-up and enrolling activities have been suspended and study closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Continued Access Protocol (CAP), prospective, multi-center, single arm study.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Convergence Of Epicardial And Endocardial RF AblationIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and < 80 years at time of enrollment consent.
- Left atrium ≤ 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view) or equivalent test.
- Refractory or intolerant to at least one AAD (class I and/or III).
- Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines.
- Provided written informed consent.
Key exclusion criteria (18 listed)
- Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure.
- Left ventricular ejection fraction < 40%.
- Pregnant or planning to become pregnant during study.
- Co-morbid medical conditions that limit one-year life expectancy.
- Previous cardiac surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Convergence Of Epicardial And Endocardial RF AblationThe 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. | Device | Single Arm |
Primary outcome
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.
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.
3 secondary outcomes
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
Effectiveness- Atrial Fibrillation burden reduction
Time frame: From 3-month blanking to 12-, 24- and 36- months post procedure evaluation
Safety-Incidence of serious adverse events
Time frame: Through 12-months post procedure visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David De Lurgio, M.D. principal investigator
Emory University
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convergence Of Epicardial And Endocardial RF Ablation in people with Atrial Fibrillation, run by AtriCure, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.