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Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban

Primary Purpose

Atrial Fibrillation, Stroke

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
WATCHMAN Left Atrial Appendage Occlusion Device
Rivaroxaban
Sponsored by
Shulin Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • Paroxysmal, persistent or permanent non-valvular atrial fibrillation
  • Eligible for LAAO and long-term rivaroxaban therapy
  • Calculated CHA2DS2-VASc score of 2 or greater.

Exclusion Criteria:

  • Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants.
  • Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment.
  • History of atrial septal repair or has an atrial septal defect/patent foramen ovale device.
  • History of valvular heart disease.
  • Implanted mechanical valve prosthesis.
  • New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 30%.
  • Patient has left atrial/left atrial appendage thrombus screened by echocardiography
  • Platelet<100*109/L or hemoglobin<100g/L
  • Expected lifespan less than 1 years

Sites / Locations

  • Beijing Anzhen Hospital
  • Nanfang Hospital
  • The first Affiliated Hospital of Guangzhou medical University
  • The first affiliated hospital of Jinan university
  • The First Affiliated Hospital of Sun Yat-sen University
  • The second Affiliated Hospital of Guangzhou medical University
  • Guangdong Cardiovascular Institute, Guangdong General Hospital
  • The Affiliated Hospital of Guangdong Medical College
  • Wuhan Asia Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WATCHMAN LAA Occlusion Device

Rivaroxaban

Arm Description

Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.

Subjects assigned to receive the Rivaroxaban therapy.

Outcomes

Primary Outcome Measures

Combined endpoint
All Stroke or Systemic embolism or Cardiovascular death

Secondary Outcome Measures

All bleeding event
Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.
Major bleeding event
An overt bleeding accompanied by one or more of the following: a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding
Technical and procedure related event
A pericardial effusion with a need for drainage, surgical or pericardiocentesis, or cardioembolic event during the procedure, or significant periprocedural bleeding (i.e. major vascular bleeding with a need for surgical revision, or blood concentrate transfusion), or device embolization, or thrombus of the device with a consequent cardioembolic event.
Cognitive function change
Montreal Cognitive Assessment(MoCA) will be performed to detect cognitive function change.The differences between the MoCA test score in WATCHMAN group and in a control group of Rivaroxaban

Full Information

First Posted
September 8, 2015
Last Updated
September 23, 2015
Sponsor
Shulin Wu
Collaborators
Wuhan Asia Heart Hospital, Beijing Anzhen Hospital, First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Medical College, First Affiliated Hospital of Jinan University, Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02549963
Brief Title
Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban
Official Title
A Prospective, Multi-Center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device With Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shulin Wu
Collaborators
Wuhan Asia Heart Hospital, Beijing Anzhen Hospital, First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Medical College, First Affiliated Hospital of Jinan University, Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WATCHMAN LAA Occlusion Device
Arm Type
Experimental
Arm Description
Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion Device.
Arm Title
Rivaroxaban
Arm Type
Active Comparator
Arm Description
Subjects assigned to receive the Rivaroxaban therapy.
Intervention Type
Device
Intervention Name(s)
WATCHMAN Left Atrial Appendage Occlusion Device
Other Intervention Name(s)
WATCHMAN Left Atrial Appendage Closure
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Novel Oral Anticoagulant
Primary Outcome Measure Information:
Title
Combined endpoint
Description
All Stroke or Systemic embolism or Cardiovascular death
Time Frame
2 year
Secondary Outcome Measure Information:
Title
All bleeding event
Description
Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.
Time Frame
2 year
Title
Major bleeding event
Description
An overt bleeding accompanied by one or more of the following: a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding
Time Frame
2 year
Title
Technical and procedure related event
Description
A pericardial effusion with a need for drainage, surgical or pericardiocentesis, or cardioembolic event during the procedure, or significant periprocedural bleeding (i.e. major vascular bleeding with a need for surgical revision, or blood concentrate transfusion), or device embolization, or thrombus of the device with a consequent cardioembolic event.
Time Frame
45 days
Title
Cognitive function change
Description
Montreal Cognitive Assessment(MoCA) will be performed to detect cognitive function change.The differences between the MoCA test score in WATCHMAN group and in a control group of Rivaroxaban
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Paroxysmal, persistent or permanent non-valvular atrial fibrillation Eligible for LAAO and long-term rivaroxaban therapy Calculated CHA2DS2-VASc score of 2 or greater. Exclusion Criteria: Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants. Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment. History of atrial septal repair or has an atrial septal defect/patent foramen ovale device. History of valvular heart disease. Implanted mechanical valve prosthesis. New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 30%. Patient has left atrial/left atrial appendage thrombus screened by echocardiography Platelet<100*109/L or hemoglobin<100g/L Expected lifespan less than 1 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shulin Wu, M.D. Ph.D.
Phone
+8613902255336
Email
doctorwushulin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xianhong Fang, M.D. Ph.D.
Phone
862083827812
Ext
10512
Email
fangxianhong2000@sina.com
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changsheng Ma, M.D. Ph.D.
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobo Huang, M.D. Ph.D.
Facility Name
The first Affiliated Hospital of Guangzhou medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang, M.D.
Facility Name
The first affiliated hospital of Jinan university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aidong Zhang, M.D. Ph.D.
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yugang Dong, M.D. Ph.D.
Facility Name
The second Affiliated Hospital of Guangzhou medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiming Liu, M.D. Ph.D.
Facility Name
Guangdong Cardiovascular Institute, Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Affiliated Hospital of Guangdong Medical College
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Chen, M.D. Ph.D.
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Xi, M.D. Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
25399274
Citation
Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum In: JAMA. 2015 Mar 10;313(10):1061.
Results Reference
background
PubMed Identifier
24998121
Citation
Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029. Erratum In: J Am Coll Cardiol. 2014 Sep 16;64(11):1186.
Results Reference
background
PubMed Identifier
21830957
Citation
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
Results Reference
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Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban

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