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aMAZE Trial Continued Access Protocol (aMAZE CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04468334
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Brief Summary:
aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of additional safety and effectiveness data at existing aMAZE investigational sites.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: LARIAT + PVI Not Applicable

Detailed Description:
For consistency, aMAZE CAP primary and secondary safety and efficacy endpoints, eligibility criteria and follow up visit assessments remain unchanged from the current aMAZE Trial investigation (NCT02517397).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LARIAT + PVI Treatment Group

Percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) with the LARIAT System prior to planned pulmonary vein isolation (PVI) catheter ablation

Subgroup 1: Radiofrequency (RF) PVI catheter ablation treatment (n<65) Subgroup 2: Cryoballoon PVI catheter ablation treatment (n<20)

Device: LARIAT + PVI
LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures
Other Names:
  • LAA + RF PVI
  • LAA + Cryo PVI




Primary Outcome Measures :
  1. Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation [ Time Frame: 12 months following Pulmonary Vein Isolation catheter ablation procedure ]
    Measured by 24-hour Holter Monitoring


Secondary Outcome Measures :
  1. Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD [ Time Frame: Following the 90 day blanking period through 12 months post-index pulmonary vein isolation ]
    Measured by 24-hour Holter Monitoring

  2. Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee [ Time Frame: 12 months following index pulmonary vein isolation ]

Other Outcome Measures:
  1. LARIAT Technical Success [ Time Frame: Immediately post-LARIAT ligation (acute) and at 12 months following index pulmonary vein isolation ]
    Successful placement of the LARIAT device pre-tied suture around the left atrial appendage to achieve left atrial appendage ligation defined as ≤1 ± 1mm diameter residual communication w/ left atrium, as assessed by transesophageal echocardiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of symptomatic continuous persistent or longstanding persistent non-valvular atrial fibrillation
  • Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible and intended for standard of care catheter ablation;
  • Life expectancy ≥ 1 year;
  • Willing and able to return to and comply with scheduled follow-up visits and tests; and
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
  • Any prior epicardial ablation or any type of left-sided atrial ablation procedure;
  • LA diameter > 6 cm as measured by computerized tomography and confirmed by the imaging core laboratory;
  • Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned study intervention;
  • Currently exhibits New York Heart Association Class IV heart failure symptoms;
  • Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
  • Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
  • Documented history of unstable angina within 3 months prior to the planned study intervention;
  • Documented history of cardiogenic shock, hemodynamic instability or any medical condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated within 3 months prior to the planned study intervention;
  • Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
  • Diagnosed active local or systemic infection, septicemia or fever of unknown origin at tme of baseline screening;
  • Chronic renal insufficiency defined as eGFR < 30 mL/min/1.73m2 withing 3 months prior to planned study intervention;
  • End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
  • Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
  • Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer;
  • Current documented use of long-term treatment with oral corticoid steroids, not including use of inhaled steroids for respiratory diseases;
  • Active pericarditis;
  • Active endocarditis;
  • Any documented history or autoimmune disease associated with pericarditis;
  • Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
  • Untreated severe scoliosis (documented and clinically defined by treating physician);
  • Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
  • Documented presence of implanted congenital defect closure devices, (e.g., atrial septal defect, patent foramen ovale or ventricular septal defect device);
  • Previously attempted occlusion of the left atrial appendage (by any surgical or percutaneous method);
  • Inability, or unwillingness or contraindication to undergo TEE or CTA imaging or 24-hour Holter monitoring;
  • Body Mass Index (BMI) > 40;
  • Evidence of active Graves disease;
  • Current untreated hypothyroidism;
  • Any contraindication to suture, endovascular device, or other minimally invasive techniques including percutaneous, transseptal, and/or sub-xiphoid access;
  • Subject is pregnant or plans / desires to get pregnant within next 12 months;
  • Current enrollment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow up;
  • Mental impairment or other psychiatric conditions which may not allow patient to understand the nature, significance and scope of the study;
  • Any other criteria, medical illness or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site Primary Investigator;

Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging

Subjects will also be excluded if they meet any of the following:

Based on screening computed tomography angiography performed within 90 days prior to study intervention as confirmed by the core lab:

Left atrial appendage morphology: Superior-posterior oriented left atrial appendage (i.e. superior C shape), that has Left atrial appendage distal apex extending posterior to the ostium of the appendage.

Left atrial appendage positioned behind the pulmonary artery; or All other left atrial morphology: Left atrial appendage LARIAT approach width > 50 mm.

Based on a peri-procedural imaging (transesophageal echocardiography) at time of LARIAT or catheter ablation) and confirmed by institution's designated LARIAT echocardiographer:

Intracardiac thrombus; or Significant mitral valve stenosis (i.e., mitral valve stenosis < 1.5cm2)

NOTE: It is anticipated that a majority of subjects enrolled in the aMAZE CAP Trial will be elderly US Medicare beneficiaries. Therefore, the results from the aMAZE CAP Trial are expected to be generalizable to the Medicare population


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468334


Contacts
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Contact: Pamelia P Simons, BS, RT 612-240-1100 psimons@atricure.com

Locations
Show Show 30 study locations
Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Principal Investigator: David J Wilber, MD Loyola University Department of Medicine
Principal Investigator: Dhanunjaya Lakkireddy, MD Kansas City Cardiac Arrhythmia Research
Publications:
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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT04468334    
Other Study ID Numbers: RS-011, Appendix 16
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by AtriCure, Inc.:
Left Atrial Appendage
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes