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Device
LARIAT + PVI for Atrial Fibrillation (aMAZE CAP Trial)
N/A
Waitlist Available
Led By Dhanunjaya Lakkireddy, MD
Research Sponsored by AtriCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following index pulmonary vein isolation
Awards & highlights
aMAZE CAP Trial Summary
This trial is an extension of a previous one investigating aMAZE CAP, which is a device used to treat heart conditions. This registry will allow for the collection of additional safety and effectiveness data from subjects who are already being treated with the device.
Who is the study for?
This trial is for adults with non-valvular atrial fibrillation who've had a bad reaction to at least one antiarrhythmic drug and are set for standard catheter ablation. They should be able to attend follow-ups, live more than a year, and not be pregnant or planning pregnancy within a year. Exclusions include severe heart failure, recent angina or myocardial infarction, infections, kidney disease requiring dialysis, pericarditis/endocarditis, autoimmune diseases affecting the heart lining, mental conditions impacting study comprehension, extreme obesity (BMI > 40), certain anatomical heart issues from imaging tests like large left atrium or intracardiac thrombus.Check my eligibility
What is being tested?
The aMAZE Trial Continued Access Protocol studies the combination of LARIAT procedure plus Pulmonary Vein Isolation (PVI) in treating atrial fibrillation. It's an extension of an existing trial allowing current sites to continue treatments and collect more data on safety and effectiveness without randomizing participants.See study design
What are the potential side effects?
While specific side effects aren't listed here, procedures like LARIAT + PVI may cause complications such as bleeding at the access site, damage to nearby structures including blood vessels or nerves around the heart; irregular heartbeat patterns that might require further treatment; pain; infection risk; and potential need for emergency procedures if complications occur.
aMAZE CAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of irregular heartbeat not caused by a heart valve issue.
Select...
I have tried and not responded to at least one heart rhythm medication.
aMAZE CAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months following index pulmonary vein isolation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following index pulmonary vein isolation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
Secondary outcome measures
Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee
Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD
Other outcome measures
LARIAT Technical Success
aMAZE CAP Trial Design
1Treatment groups
Experimental Treatment
Group I: LARIAT + PVI Treatment GroupExperimental Treatment1 Intervention
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LARIAT + PVI
2020
N/A
~90
Find a Location
Who is running the clinical trial?
AtriCure, Inc.Lead Sponsor
42 Previous Clinical Trials
17,469 Total Patients Enrolled
27 Trials studying Atrial Fibrillation
8,345 Patients Enrolled for Atrial Fibrillation
Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Cardiac Arrhythmia Research
28 Previous Clinical Trials
8,142 Total Patients Enrolled
14 Trials studying Atrial Fibrillation
3,794 Patients Enrolled for Atrial Fibrillation
David J Wilber, MDPrincipal InvestigatorLoyola University Department of Medicine
2 Previous Clinical Trials
772 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
772 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing heart infection.My kidney function is low, with an eGFR under 30.I had a heart attack within the last 3 months.I have had radiation therapy for breast cancer only.I've had heart surgery that might have caused scar tissue around my heart.My heart's left atrium is larger than 6 cm, confirmed by a CT scan.I have had unstable chest pain in the last 3 months.I have an autoimmune disease linked to pericarditis.I have active inflammation of the heart lining.My doctor has confirmed I have severe scoliosis that hasn't been treated.You have a medical device implanted to close a specific type of heart defect.I do not have an ongoing infection, septicemia, or unexplained fever.I have end-stage kidney disease or have been on dialysis.My heart's left atrial appendage is behind the pulmonary artery or is wider than 50 mm.My doctor has confirmed I have Pectus Excavatum.I have had a procedure to treat heart rhythm problems on the left side of my heart.I have an underactive thyroid that hasn't been treated.I have severe narrowing in my carotid artery with symptoms.I cannot have certain minimally invasive procedures due to health reasons.I have had severe heart issues or needed heart pump support in the last 3 months.I have severe heart failure symptoms.I have been diagnosed with a type of irregular heartbeat not caused by a heart valve issue.You have a history of right heart failure, especially if the right side of your heart is bigger than the left side.I understand the study's details and can make informed decisions.I have tried to block my left atrial appendage before.I am currently on long-term oral steroid treatment, not including inhaled steroids.You are expected to live for at least 1 year.I had a stroke or a mini-stroke in the last 3 months.I have active Graves' disease.You have a very high body weight compared to your height.I cannot or do not want to have certain heart imaging tests or monitoring.I have tried and not responded to at least one heart rhythm medication.A special heart imaging test showed a blood clot inside the heart, or a narrow mitral valve.I have a liver condition that increases my risk of bleeding.My heart's pumping ability is significantly reduced.A special heart scan shows that the left atrial appendage has a specific shape and position.
Research Study Groups:
This trial has the following groups:- Group 1: LARIAT + PVI Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there numerous health care facilities that are running this research within the state's boundaries?
"Northwestern Medicine Central DuPage Hospital in Winfield, Texas, Baylor - St. Luke's Medical Center in Houston, Washington and Providence Sacred Heart Medical Center in Spokane, Tennessee are some of the 34 locations with enrollment sites for this study."
Answered by AI
Am I eligible to participate in this trial?
"This clinical trial is recruiting 85 individuals aged between 18 and 80 with atrial fibrillation. To qualify, applicants must have failed one Class I or III Antiarrythmic drug (AAD), be willing to attend follow-up visits, have an expected life expectancy of more than 12 months, and agree to undergo standard catheter ablation procedures."
Answered by AI
Are there any enrolment opportunities available for this research?
"Clinicaltrials.gov states that this particular trial, which was first registered on March 9th 2020 and last updated on July 18 2022, is no longer recruiting participants; however 477 other studies are actively enrolling patients."
Answered by AI
Is there an age restriction in place for this medical experiment?
"Eligibility for this clinical trial is contingent on the patient's age falling between 18 and 80 years old. This study has 11 trials specifically designed to accommodate minors, and 474 that are tailored for those over 65."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Northwestern Medicine Central DuPage Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
What questions have other patients asked about this trial?
Is this a paid trial?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Have afib but other things too. Maybe you can figure it out.
PatientReceived 1 prior treatment
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