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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02549963
• Other study ID #: GDCI 201501
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 8, 2015
• Last updated: September 23, 2015
• Start date: October 2015

Study information

• Verified date: September 2015
• Source: Guangdong General Hospital
• Contact: Shulin Wu, M.D. Ph.D.
• Phone: +8613902255336
• Email: doctorwushulin[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Device:
• WATCHMAN Left Atrial Appendage Occlusion Device

Drug:
• Rivaroxaban

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing
China	Guangdong Cardiovascular Institute, Guangdong General Hospital	Guangzhou	Guangdong
China	Nanfang Hospital	Guangzhou	Guangdong
China	The first Affiliated Hospital of Guangzhou medical University	Guangzhou	Guangdong
China	The first affiliated hospital of Jinan university	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The second Affiliated Hospital of Guangzhou medical University	Guangzhou	Guangdong
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	The Affiliated Hospital of Guangdong Medical College	Zhanjiang	Guangdong

Sponsors (9)

Lead Sponsor	Collaborator
Shulin Wu	Beijing Anzhen Hospital, First Affiliated Hospital of Jinan University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Medical College, Nanfang Hospital of Southern Medical University, Second Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint	All Stroke or Systemic embolism or Cardiovascular death	2 year	No
Secondary	All bleeding event	Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.	2 year	Yes
Secondary	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	2 year	Yes
Secondary	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.	45 days	Yes
Secondary	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	2 year	No