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Atrial FibrillationaMAZE CAPNCT04468334

aMAZE Trial Continued Access Protocol

A study testing LARIAT + PVI in people with Atrial Fibrillation, run by AtriCure, Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
LARIAT + PVI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
25 sitesUnited States
Study dates
9 Mar 2020to 24 Apr 2023
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

  • 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

Who cannot join

  • 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;
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  • 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 within 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Emory University Hospital

    Atlanta, Georgia, 30342

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Northwestern University / Bluhm Cardiovascular Institute

    Chicago, Illinois, 60611

  • Cardiovascular Institute of the South Clinical Research Corporation

    Houma, Louisiana, 70360

  • Baylor - St. Luke's Medical Center

    Houston, Texas, 77030

  • St. Vincent's HealthCare

    Jacksonville, Florida, 32204

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • UP Health System- Marquette

    Marquette, Michigan, 49855

  • Loyola University Center for Heart and Vascular Medicine

    Maywood, Illinois, 60153

  • Southern Oregon Cardiology

    Medford, Oregon, 97504

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Kansas City Cardiac Arrhythmia Research

    Overland Park, Kansas, 66215

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • University of California San Francisco

    San Francisco, California, 94143

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62769

  • Stanford University

    Stanford, California, 94305

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Northwestern Medicine Central DuPage Hospital

    Winfield, Illinois, 60190

Other trials in United States

About this study

Official title: Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)

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.

Read the 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).

Being tested
LARIAT + PVI
Keywords
Left Atrial Appendage
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LARIAT + PVIDevice

    Also called LAA + RF PVI, LAA + Cryo PVI

    LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures

Study groups in NCT04468334
Study groupRoleWhat they receive
LARIAT + PVI Treatment GroupExperimentalPercutaneously 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)
Receives: Device: LARIAT + PVI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation

    Measured by 24-hour Holter Monitoring

    Measured: 12 months following Pulmonary Vein Isolation catheter ablation procedure

Secondary outcomes (2)

  1. Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD

    Measured by 24-hour Holter Monitoring

    Measured: Following the 90 day blanking period through 12 months post-index pulmonary vein isolation

  2. Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee

    Measured: 12 months following index pulmonary vein isolation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start9 Mar 2020
  3. Primary completion24 Apr 2023
  4. Study completion24 Apr 2023

Resources

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
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468334
Sponsor's protocol ID
RS-011, Appendix 16
Acronym
aMAZE CAP
Status last verified
Apr 2023
First submitted
8 Jul 2020
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Lee RJ, Lakkireddy D, Mittal S, Ellis C, Connor JT, Saville BR, Wilber D. Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design. Am Heart J. 2015 Dec;170(6):1184-94. doi: 10.1016/j.ahj.2015.09.019. Epub 2015 Oct 3.

    PubMed 26678640

Questions about this trial

What is this clinical trial studying?

A study testing LARIAT + PVI in people with Atrial Fibrillation, run by AtriCure, Inc. at 25 sites in United States.

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 41 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04468334, which also lists 1 linked publication.

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 12 Mar 2024.

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aMAZE Trial Continued Access Protocol (NCT04468334) | AzTrials