AMPLATZER Cardiac Plug Clinical Trial

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AMPLATZER Cardiac Plug

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring ACP, Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Dabigatran, Pradaxa, Blood thinning medication, Left atrial appendage, LAA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device

Optimal Medical Therapy (control)

Arm Description

AMPLATZER Cardiac Plug

Warfarin Dabigatran

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01118299

First Posted

May 5, 2010

Last Updated

April 2, 2020

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT01118299

Brief Title

AMPLATZER Cardiac Plug Clinical Trial

Official Title

Amplatzer Cardiac Plug Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 26, 2010 (Actual)

Primary Completion Date

December 6, 2018 (Actual)

Study Completion Date

December 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism

Keywords

ACP, Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Dabigatran, Pradaxa, Blood thinning medication, Left atrial appendage, LAA

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device

Arm Type

Experimental

Arm Description

AMPLATZER Cardiac Plug

Arm Title

Optimal Medical Therapy (control)

Arm Type

Active Comparator

Arm Description

Warfarin Dabigatran

Intervention Type

Device

Intervention Name(s)

AMPLATZER Cardiac Plug

Intervention Description

AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Primary Outcome Measure Information:

Title

Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only

Description

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.

Time Frame

From Randomization to Discharge Visit

Title

Long-term Safety - Device Arm Only

Description

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.

Time Frame

Randomization to 2 year follow-up

Title

Effectiveness Endpoint - Device Arm Only

Description

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.

Time Frame

Randomization through 2 year follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Facility Information:

Facility Name

Good Samaritan Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

University of Colorado Denver

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

South Denver Cardiology Associates

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

Emory Midtown Hospital and Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

St. Joseph's Hospital and Research Institute

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

University of Iowa Hospitals & Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40506

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Spectrum Health

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Providence Hospital

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48075

Country

United States

Facility Name

St. Cloud Hospital/CentraCare Heart and Vascular Clinic

City

Saint Cloud

State/Province

Minnesota

ZIP/Postal Code

56303

Country

United States

Facility Name

HealthEast St. Joseph's Hospital

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

York Hospital

City

York

State/Province

Pennsylvania

ZIP/Postal Code

17405

Country

United States

Facility Name

Roper Hospital/PMG Research of Charleston

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

Country

United States

Facility Name

Memorial Hermann Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Aspirus Heart & Vascular Institute

City

Wausau

State/Province

Wisconsin

ZIP/Postal Code

54401

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.americanheart.org/downloadable/heart/119618028569709%20WhatisAtrialFibrillation%209_07.pdf

Description

What is Atrial Fibrillation - Fact Sheet

URL

http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html

Description

Overview of Atrial Fibrillation

URL

http://www.americanheart.org/downloadable/heartsmart/118582358042250-0066%20ASA%20TIAWrngSigns_4-07.pdf

Description

Let's Talk about Stroke, TIA and Warning Signs - Fact Sheet

Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial