Amplatzer Amulet China Post Market Study (PMS)

Non-Valvular Atrial Fibrillation Clinical Trial

Official title:

Amplatzer Amulet China Post Market Study (PMS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189365
• Other study ID #: ABT-CIP-10491
• Secondary ID: CRD_1028
• Status: Recruiting
• Start date: January 30, 2024
• Est. completion date: January 31, 2030

Study information

• Verified date: April 2024
• Source: Abbott Medical Devices
• Contact: Rio ZHAN
• Phone: +86 21 2320 4181
• Email: wanlei.zhan[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Description:

Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. During AF, chaotic electrical activity results in rapid, uncoordinated, and insufficient contractions of the atrial chambers. Stagnation of blood flow in the left atrium (LA) can lead to hypercoagulability. The left atrial appendage (LAA), given its location and complex shape is often the primary site of stasis and thus increases the risk for thrombus formation. Approximately 90% of all thrombi in patients with non-valvular AF (NVAF) forming in the LA originate in the LAA.

Patients with NVAF are at an increased risk of systemic embolism and stoke due to the potential for clot forming in the LAA. OAC is the recommended first-line therapy for NVAF at increased risk of stroke, however, many patients have relative or absolute contraindications to taking OACs. LAAO offers a non-pharmacological option for stroke risk reduction in these patients unable to take OAC.

The Amulet occluder is Abbott's second-generation LAA occlusion device. It received CE Mark in 2013, and FDA approval in August 2021. Observational studies performed in multiple geographies show that the Amulet occluder can be safely implanted with good procedural outcomes and reduce the risk of stroke as compared to a predicted rate without the need for anticoagulation in most patients. This led to the National Medical Products Administration (NMPA) approval of the Amulet occluder in 2020.

The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2030
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events

2. Meets the current device indications and per physician discretion for Amulet implant

3. Able to provide written Informed Consent prior to any study related procedures

4. 18 years of age or older at the time of enrolment

Exclusion Criteria:

1. With the presence of intracardiac thrombus

2. With active endocarditis or other infections producing bacteremia

3. Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score < 3)

4. Where placement of the device would interfere with any intracardiac or intravascular structures

5. Has a life expectancy of less than 2 years due to any condition

6. Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-Valvular Atrial Fibrillation

Intervention

Device:
• Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder
Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder.

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	University of Hong Kong-Shenzhen Hospital	Shenzhen	Guangdong
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of ischemic stroke or systemic embolism	Rate of ischemic stroke or systemic embolism through 5 years post-implant	5 years
Other	Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade	Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade through 5 years post-procedure	5 years
Other	Rate of device success	Rate of device success - defined as device deployed and implanted in correct position	During implant procedure, approximately 30 to 60 minutes
Other	Rate of device closure	Rate of device closure - defined as residual jet around the device of = 5mm, based on the 3 month transesophageal echocardiogram (TEE) defined by Doppler flow	3 months
Other	Percentage of subjects taking OAC or antiplatelet drugs	Percentage of subjects taking OAC or antiplatelet drugs through 5 years	5 years
Primary	Occurrence of major adverse events	The primary short-term safety endpoint is the occurrence of one or more of the following major adverse events within 7 days after the procedure: all-cause mortality, procedure or device-related complications requiring open cardiac surgery or major endovascular intervention, ischemic or hemorrhagic stroke, or systemic embolism.	7 days
Primary	Occurrence of device embolization,device erosion,clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections(endocarditis and pericarditis), device breakage, or device related allergy	The primary long-term safety endpoint is the occurrence of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections (endocarditis and pericarditis), device breakage, or device related allergy through 2 years.	2 years
Primary	Composite of ischemic stroke or systemic embolism	The primary effectiveness endpoint is a composite of ischemic stroke or systemic embolism through 2 years.	2 years