WATCHMAN for Second Prevention of Stroke (WASPS)

NCT03327350 | Unknown DMC FDA Drug FDA Device

• 1 other identifier: SAHZJU CT009
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of stroke in the patients with nonvalvular atrial fibrillation

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• All stroke (including ischemic and hemorrhagic) and systemic embolism, cardiovascular death (limited to any cardiovascular and unexplained)

  3 years

Secondary Outcomes (2)

• All the serious complications,including the surgery complications and major bleeding events.

  3 years

• All-cause death

  3 years

Study Arms (2)

WATCHMAN transplantation

This group will receive WATCHMAN device implantation.Device implantation included concomitant antithrombotic medication to facilitate device endothelialization: warfarin and aspirin for 45 days. To assess for device stability, peridevice leaks, and device-related thrombus, transesophageal echo (TEE) imaging was performed at 45 days, 6 months, and 12 months. When the 45-day TEE revealed minimal residual peridevice flow (jet width ≤5 mm) and no device-related thrombus, warfarin will be stopped and replaced by clopidogrel, 75 mg daily, until the 6-month visit, after which only aspirin was continued. If an adequate seal is not obtained or a thrombus is detected, patients continue taking warfarin until an adequate seal is attained or thrombus is resolved before transitioning to aspirin.

Device: WATCHMAN transplantation

Oral anticoagulant therapy

This group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ). For patients taking warfarin, international normalized ratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Follow-up visits occurred twice annually after the first year, with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected.

Drug: Oral anticoagulant drugs

Interventions

WATCHMAN transplantation DEVICE

WATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic

WATCHMAN transplantation

Oral anticoagulant drugs DRUG

This group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ).For patients taking warfarin,international normalizedratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Followup visits occurred twice annually after the first year,with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected.

Oral anticoagulant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

400 hospitalized patients over 18 years old with nonvalvular atrial fibrillation will be enrolled consecutively

You may qualify if:

• Age 18 years or older;
• A history of stroke/transient ischemic attack(TIA) over 3 months;
• Paroxysmal, persistent, or permanent nonvalvular AF;
• or more CHA2DS2-VASc risk factors
• Eligibility for long-term anticoagulation with warfarin or new oral anticoagulants.

You may not qualify if:

• patent foramen ovale with atrial septal aneurysm
• an atrial septal defect
• mechanical valve prosthesis
• left ventricular ejection fraction less than 30%
• mobile aortic atheromata
• symptomatic carotid disease

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jian-an Wang, MD,PhD

  Second Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: October 31, 2017
• Study Start: November 5, 2017
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 31, 2017

Record last verified: 2017-01

Locations

CN (1)