Purpose

This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2) - Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (ENROLLING) All subjects from both stages will be included in the primary analysis.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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;
  • 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;
  • Body Mass Index (BMI) > 40. Investigator may petition for independent adjudication based on subject body habitus;
  • 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 Trial will be elderly US Medicare beneficiaries. Therefore, the results from the aMAZE Trial are expected to be generalizable to the Medicare population.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Device: LARIAT + PVI
    Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures
    Other names:
    • Left Atrial Appendage ligation + Pulmonary Vein Isolation
  • Device: Pulmonary Vein Isolation
    Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
Active Comparator
PVI Catheter Ablation Group
Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
  • Device: Pulmonary Vein Isolation
    Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Dalvert Polanco, M.D.
718-920-6442
DAPOLANC@montefiore.org

More Details

NCT ID
NCT02513797
Status
Recruiting
Sponsor
SentreHEART, Inc.

Study Contact

Pamela P Simons, BS, RT
650-241-6011
psimons@sentreheart.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.