AMPLATZER Cardiac Plug Clinical Trial
This study is currently recruiting participants.
Verified April 2013 by AGA Medical Corporation
Sponsor:
AGA Medical Corporation
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT01118299
First received: May 5, 2010
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation Ischemic Stroke Peripheral Thromboembolism |
Device: AMPLATZER Cardiac Plug |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by AGA Medical Corporation:
Primary Outcome Measures:
- Acute Safety [ Time Frame: Randomization until Hospital Discharge ] [ Designated as safety issue: Yes ]An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques.
- Long-term safety [ Time Frame: Randomization to 2 year follow-up ] [ Designated as safety issue: Yes ]An analysis comparing safety events (all-cause death and major bleeding) that occur between the device arm and the control arm.
- Effectiveness endpoint [ Time Frame: Randomization through 2 year follow up ] [ Designated as safety issue: No ]Occurrence of ischemic stroke and peripheral thromboembolism
Secondary Outcome Measures:
- Acute clinical success [ Time Frame: In-hospital to 45 days post procedure ] [ Designated as safety issue: Yes ]No reported in-hospital serious adverse events, closure of LAA documented at Day 45 TEE, no ischemic stroke or peripheral thromboembolism and discontinuation of warfarin or dabigatran.
- Long-term clinical success [ Time Frame: Implant to at least 6 months follow-up ] [ Designated as safety issue: Yes ]No reported in-hospital serious adverse events, closure of LAA documented at Day 45 TEE, no ischemic stroke or peripheral thromboembolism and sustained discontinuation of warfarin or dabigatran at last available follow-up.
- Adverse Events [ Time Frame: Randomization through required follow-ups ] [ Designated as safety issue: Yes ]
Assessing adverse events:
- Device embolization
- Myocardial perforation (hemopericardium) or any pericardial effusion requiring drainage
- Endocarditis
- Thrombus on device
- Asymptomatic intracerebral or intraventricular hemorrhage
- Transient Ischemic Attack
- Atrial Fibrillation Status [ Time Frame: Randomization through required follow-ups ] [ Designated as safety issue: No ]Subjects who progress from paroxysmal to persistent AF or subjects who progress from persistent to permanent AF.
- Technical success [ Time Frame: Procedure ] [ Designated as safety issue: No ]Delivery and release of the ACP device, including recapture and/or replacement, as necessary.
- Complete Closure [ Time Frame: 6 month ] [ Designated as safety issue: No ]Absence of flow into the LAA as assessed by TEE at 6 months.
| Estimated Enrollment: | 3000 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Device
AMPLATZER Cardiac Plug
|
Device: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
|
|
Active Comparator: Optimal Medical Therapy (control)
Warfarin Dabigatran
|
Device: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
- Subject must be ≥18 years of age
- Subject must be on warfarin or dabigatran therapy
- Subject must be eligible for long term warfarin or dabigatran therapy
- Subject must have a CHADS(2) score of 2 or greater
Summary of Exclusion Criteria:
- Subject who requires warfarin or dabigatran for a condition other than AF
- Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
- Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
- Subject with a New York Heart Association (NYHA) classification equal to IV
- Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
- Subject with aortic or mitral valve regurgitation of grade 2+ or greater
- Subject with left ventricular ejection fraction (LVEF) ≤30
- Subject with mitral or aortic prosthetic valve
- Subject with a history of hemorrhagic or aneurysmal stroke
- Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
- Subject with a body mass index (BMI) ≥40
- Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
- Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118299
Contacts
| Contact: Sarah Gallagher | 651-756-6937 | sgallagher02@sjm.com |
Locations
| United States, Alabama | |
| Huntsville Hospital | Not yet recruiting |
| Huntsville, Alabama, United States, 35801 | |
| Principal Investigator: Warren Strickland, MD | |
| United States, California | |
| Good Samaritan Hospital | Active, not recruiting |
| Los Angeles, California, United States, 90017 | |
| Cedars-Sinai Medical Center | Active, not recruiting |
| Los Angeles, California, United States, 90048 | |
| United States, Colorado | |
| University of Colorado Denver | Active, not recruiting |
| Aurora, Colorado, United States, 80045 | |
| South Denver Cardiology Associates | Active, not recruiting |
| Littleton, Colorado, United States, 80120 | |
| United States, Iowa | |
| University of Iowa Hospitals & Clinics | Active, not recruiting |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| University of Kentucky | Active, not recruiting |
| Lexington, Kentucky, United States, 40506 | |
| United States, Michigan | |
| Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Stacie VanOosterhout, MEd, CCRC Stacie.vanoosterhout@spectrumhealth.org | |
| Principal Investigator: William Merhi, DO | |
| Providence Hospital | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Contact: AnneMarie Forrest, RN 248-849-3102 | |
| Principal Investigator: Christian Machado, MD | |
| United States, Minnesota | |
| HealthEast St. Joseph's Hospital | Recruiting |
| St. Paul, Minnesota, United States, 55102 | |
| Contact: Beth Jorgenson, RN, BSN, MBA, CCRC bjorgenson@healtheast.org | |
| Contact: Joy Gilliam jegilliam@healtheast.org | |
| Principal Investigator: Stuart Adler, MD | |
| Principal Investigator: Carmelo Panetta, MD | |
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Jennifer Bremer, RN, BSN 614-685-4622 jennifer.bremer@osumc.edu | |
| Principal Investigator: Steven Kalbfleisch, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Active, not recruiting |
| Philadelphia, Pennsylvania, United States, 19104-6006 | |
| York Hospital | Recruiting |
| York, Pennsylvania, United States, 17405 | |
| Contact: Sharon Gates, RN, BS 717-851-3408 sgates@wellspan.org | |
| Principal Investigator: William Nicholson, MD | |
| United States, Texas | |
| The Heart Hospital Baylor | Recruiting |
| Plano, Texas, United States, 75093 | |
| Contact: Geoffrey Gong 469-814-4732 | |
| Principal Investigator: Srinivasa Potluri, MD | |
Sponsors and Collaborators
AGA Medical Corporation
More Information
Additional Information:
No publications provided
| Responsible Party: | AGA Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT01118299 History of Changes |
| Other Study ID Numbers: | CL00921 |
| Study First Received: | May 5, 2010 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AGA Medical Corporation:
|
ACP Atrial Fibrillation AF A Fib Stroke Coumadin |
Warfarin Dabigatran Pradaxa Blood thinning medication Left atrial appendage LAA |
Additional relevant MeSH terms:
|
Atrial Fibrillation Stroke Thromboembolism Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Embolism and Thrombosis Thrombosis |
ClinicalTrials.gov processed this record on May 16, 2013