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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04468334 |
|
Recruitment Status :
Active, not recruiting
First Posted : July 13, 2020
Last Update Posted : April 12, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Device: LARIAT + PVI | Not Applicable |
| 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 : | March 9, 2020 |
| Estimated Primary Completion Date : | July 2023 |
| Estimated Study Completion Date : | March 2025 |
| 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:
|
- 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
- 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
- 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 ]
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | 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 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 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
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
Show 25 study locations
| Principal Investigator: | David J Wilber, MD | Loyola University Department of Medicine | |
| Principal Investigator: | Dhanunjaya Lakkireddy, MD | Kansas City Cardiac Arrhythmia Research |
| 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: | April 12, 2023 |
| Last Verified: | April 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
|
Left Atrial Appendage |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |