AMPLATZER Cardiac Plug Clinical Trial

Atrial Fibrillation Clinical Trial

Official title:

Amplatzer Cardiac Plug Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118299
• Other study ID #: CL00921
• Status: Completed
• Phase: N/A
• Start date: April 26, 2010
• Est. completion date: December 6, 2018

Study information

• Verified date: April 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 6, 2018
• Est. primary completion date: December 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemic Stroke
• Peripheral Thromboembolism
• Thromboembolism

Intervention

Device:
• AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Locations

Country	Name	City	State
United States	Emory Midtown Hospital and Emory University Hospital	Atlanta	Georgia
United States	St. Joseph's Hospital and Research Institute	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Roper Hospital/PMG Research of Charleston	Charleston	South Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	Memorial Hermann Hospital	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Kentucky	Lexington	Kentucky
United States	South Denver Cardiology Associates	Littleton	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Good Samaritan Hospital	Los Angeles	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Cloud Hospital/CentraCare Heart and Vascular Clinic	Saint Cloud	Minnesota
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Providence Hospital	Southfield	Michigan
United States	Aspirus Heart & Vascular Institute	Wausau	Wisconsin
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only	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.; The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).; However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol.	From Randomization to Discharge Visit
Primary	Long-term Safety - Device Arm Only	All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).; However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.	Randomization to 2 year follow-up
Primary	Effectiveness Endpoint - Device Arm Only	Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).; However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.	Randomization through 2 year follow up

External Links

•   Let's Talk about Stroke, TIA and Warning Signs - Fact Sheet
•   Overview of Atrial Fibrillation
•   What is Atrial Fibrillation - Fact Sheet