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CONVERGE Post-Approval Study (PAS)

Primary Purpose

Chronic Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF

About this trial

This is an interventional treatment trial for Chronic Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years and < 80 years at time of enrollment consent;
Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality;
Refractory or intolerant to at least one AAD (class I and/or III);
Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF);
Life expectancy > 12 months; and
Provides written informed consent.

Exclusion Criteria:

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 < 35%;
Pregnant or planning to become pregnant during study;
Co-morbid medical conditions that limit one-year life expectancy;
Previous cardiac surgery;
History of pericarditis;
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);
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;
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
Presence of Barretts esophagitis

Sites / Locations

Hoag Memorial Hospital PresbyterianRecruiting
Baycare Health SystemsRecruiting
Emory Saint Joseph HopsitalRecruiting
MedStar Union Memorial HospitalRecruiting
Southcoast Hospitals GroupRecruiting
Wake Forest University Health SciencesRecruiting
Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hybrid Convergent

Arm Description

Once the procedure intra-op exclusion conditions have been evaluated, the Epicardial linear lesions will be created endoscopically using the EPi-Sense®-AF Guided Coagulation System 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 complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. 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.

Outcomes

Primary Outcome Measures

Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD.

Primary Effectiveness Endpoint: The primary effectiveness endpoint is defined as the number of participants that exhibit 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 90-day blanking period through the 12-months post procedure follow-up visit. The primary effectiveness endpoint will be evaluated based on the first 24 hours of the 7-days Holter monitoring. Participants will be considered failures if any of the following conditions are observed: AF/AFL/AT greater than 30 seconds, new or increased dose of previously failed AAD through 12 month post procedure visit, Cardioversion through 12 months post procedure, left sided catheter ablation through 12 months post procedure and catheter ablation for right sided typical atrial flutter. Failures will be compared to total cohort to establish a success rate.

Primary Safety Endpoint, Incidence of defined Major Adverse Events

The primary safety endpoint for the study is defined as the number of participants that exhibit device or procedure-related major adverse events (MAEs) for subjects undergoing the Hybrid Convergent procedure from the index procedure through 30-days post procedure. Participants will be considered failures if the following is exhibted: Pericardial effusions with cardiac tamponade defined as effusions resulting in hemodynamic compromise. Severe pulmonary vein (PV) stenosis Excessive bleeding requiring reoperation Myocardial infarction (MI); Stroke, transient ischemic attacks (TIA); Atrioesophageal fistula (AEF) through 3-months post-procedure; Phrenic nerve injury Death Failures will be compared to total cohort of participants to establish success rate.

Secondary Outcome Measures

Incidence of significant pericardial effusion

• Number of participants that exhibit clinically significant pericardial effusions that require percutaneous or surgical treatment post-procedure. A significant pericardial effusion in one which results in hemodynamic compromise, requires elective or urgent pericardiocentesis, or results in 1 cm or more pericardial effusion as documented by echocardiography. Failures will be compared to total cohort of participants to establish success rate.

Incidence of Serious Adverse Events (SAE) through 12 months

• Device and procedure-related serious adverse events reported through 12 months post-procedure

Increase or decrease in AF symptoms from baseline

• Change in AF symptoms from baseline to 12-, 18-, 24- and 36- months post-procedure based on Quality of Life (QoL) assessment using The Atrial Fibrillation Effect on Quality-of-life Questionnaire ( AFEQT)

Freedom from AF/AT/AFL >30 seconds with previously or intolerant failed class I/III AAD

• Freedom from AF/AT/AFL >30 seconds duration 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 90-day blanking period through the 12-months post procedure follow-up visit. Evaluated based on the first 24 hours of the 7-days Holter monitoring and symptom-driven event monitoring

Freedom from any AF/AFL/AT >30 seconds without a Class I/III

• Freedom from any AF/AFL/AT >30 seconds duration without a Class I/III AAD prescribed for AF following the 90-day blanking period through 12- 18-, 24- and 36- months post-procedure

Freedom from any AF/AFL/AT >30 seconds with or without a Class I/III AAD

• Freedom from any AF/AFL/AT >30 seconds duration with or without an AAD prescribed for AF following the 90-day blanking period through 12-, 18-, 24- and 36- months post -procedure

Number of participants with a reduction of AF burden

• Residual AF burden / reduction in overall AF burden at 12-, 18-, 24- and 36-months post procedure when compared to baseline. No change or increase in burden will be considered a failure. Failures will be compared to total cohort of participants to establish success rate compared to baseline.

Number of Participants with an decrease in AFEQT Questionnaire Quality of Life (Qol) Score

• Change in AF-specific Quality of Life (QoL) score(s) at 12-, 18-, 24- and 36- months post-index procedure when compared to baseline score. The increase in scores will be compared to baseline to determine comparative success or failure.

Number of participants with less than 30 seconds of AF/AFL/AT

Freedom from AF/AFL/AT effectiveness secondary endpoints at 12-months will be evaluated from the 7-day rhythm recording and, also from the first 24 hours of a 7-days Holter. Freedom from AF/AFL/AT effectiveness secondary endpoints at 18-, 24- and 36- months will be evaluated from the 7-day rhythm recording. All burden effectiveness endpoints will be assessed from 7-days Holter for all subjects and separately for subjects with ILR/PPM data. Success or failure will be defined as AF/AFL/AT greater than 30 seconds duration. Failures will be compared to total cohort of participants to establish success rate.

Full Information

NCT ID

NCT05393180

First Posted

June 24, 2021

Last Updated

April 25, 2023

Sponsor

AtriCure, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05393180

Brief Title

CONVERGE Post-Approval Study (PAS)

Official Title

Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 13, 2022 (Actual)

Primary Completion Date

November 1, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AtriCure, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Detailed Description

In accordance with FDA's Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency's PMA approval of the CONVERGE pivotal trial. Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold. The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients. The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options. A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to: Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals. Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates. Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience. Collect and report on long term outcomes of the Hybrid Convergent procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, multi-center, open-label, single arm (Hybrid Convergent only) post-approval study

Masking

None (Open Label)

Allocation

N/A

Enrollment

325 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hybrid Convergent

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF

Intervention Description

Epicardial linear lesions will be created endoscopically using the EPi-Sense®-AF Guided Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. This will be done endocardially using an irrigated endocardial ablation catheter. 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 Measure Information:

Title

Freedom from AF/AFL/AT >30 seconds through 12 months absent new or increased dose of class I/III AAD.

Description

Time Frame

1 year

Title

Primary Safety Endpoint, Incidence of defined Major Adverse Events

Description

Time Frame

30-days post procedure

Secondary Outcome Measure Information:

Title

Incidence of significant pericardial effusion

Description

Time Frame

12 months

Title

Incidence of Serious Adverse Events (SAE) through 12 months

Description

• Device and procedure-related serious adverse events reported through 12 months post-procedure

Time Frame

12 months

Title

Increase or decrease in AF symptoms from baseline

Description

Time Frame

3 years

Title

Freedom from AF/AT/AFL >30 seconds with previously or intolerant failed class I/III AAD

Description

Time Frame

12 months

Title

Freedom from any AF/AFL/AT >30 seconds without a Class I/III

Description

• Freedom from any AF/AFL/AT >30 seconds duration without a Class I/III AAD prescribed for AF following the 90-day blanking period through 12- 18-, 24- and 36- months post-procedure

Time Frame

3 years

Title

Freedom from any AF/AFL/AT >30 seconds with or without a Class I/III AAD

Description

• Freedom from any AF/AFL/AT >30 seconds duration with or without an AAD prescribed for AF following the 90-day blanking period through 12-, 18-, 24- and 36- months post -procedure

Time Frame

3 years

Title

Number of participants with a reduction of AF burden

Description

Time Frame

3 years

Title

Number of Participants with an decrease in AFEQT Questionnaire Quality of Life (Qol) Score

Description

Time Frame

3 years

Title

Number of participants with less than 30 seconds of AF/AFL/AT

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years and < 80 years at time of enrollment consent; Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality; Refractory or intolerant to at least one AAD (class I and/or III); Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF); Life expectancy > 12 months; and Provides written informed consent. Exclusion Criteria: 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 < 35%; Pregnant or planning to become pregnant during study; Co-morbid medical conditions that limit one-year life expectancy; Previous cardiac surgery; History of pericarditis; 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); 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; Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results Presence of Barretts esophagitis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Denise Breiner

Phone

513-658-9643

dbreiner@atricure.com

First Name & Middle Initial & Last Name or Official Title & Degree

William Beecher

Phone

414-418-7913

wbeecher@atricure.com

Facility Information:

Facility Name

Hoag Memorial Hospital Presbyterian

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gene Graham, RN

Phone

951-833-4363

gene.graham@hoag.org

First Name & Middle Initial & Last Name & Degree

Terry Taylor, RN

Phone

949-764-4509

Terry.Taylor@hoag.org

First Name & Middle Initial & Last Name & Degree

Michael S. Panutich, MD

Facility Name

Baycare Health Systems

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33759

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karren Herring, RN

Phone

813-533-1412

Ext

280209

karen.herring@baycare.org

First Name & Middle Initial & Last Name & Degree

Kevin Makati, MD

Facility Name

Emory Saint Joseph Hopsital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cindy Barnes, CRC

Phone

678-843-6093

pfsmith@emory.edu

First Name & Middle Initial & Last Name & Degree

David DeLurgio, MD

Facility Name

MedStar Union Memorial Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21218

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kieth Moyer

Phone

443-278-9170

Ext

keith.moyer@medstar.net

First Name & Middle Initial & Last Name & Degree

Rebecca Comaty

Phone

443-278-9170

Ext

First Name & Middle Initial & Last Name & Degree

Brain Bethea, MD

Facility Name

Southcoast Hospitals Group

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02740

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Debra Benevides, NP

Phone

508-973-7328

benevidesd@southcoast.org

First Name & Middle Initial & Last Name & Degree

Nitesh Sood, MD

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelli Byrd

Phone

336-713-7024

kbyrd@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Ghanshyam Shanta, M.D.

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Machuca

Phone

972-358-6205

daniel.muchuca@vmfh.org

First Name & Middle Initial & Last Name & Degree

Robert Moraca, M.D>

12. IPD Sharing Statement

Learn more about this trial

CONVERGE Post-Approval Study (PAS)

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