Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry

NCT01972295 | Completed

• 1 other identifier: 90879496
• Study Type: observational
• Target: 201
• Locations: 7 countries
• Sites: 9

Brief Summary

This is an observational, prospective, non-randomized, multicenter study with the following objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect health care usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Procedural complications, Stroke and Death

  Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.

  at implant and 2 year follow up

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

Patients with non-valvular atrial fibrillation

You may qualify if:

• Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion;
• Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
• Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

You may not qualify if:

• Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
• The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (9)

Royal Adelaide Hospital

Adelaide, Australia

Location

Greenslopes

Brisbane, Australia

Location

Monash Medical

Melbourne, Australia

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Medistra Hospital

Jakarta, Indonesia

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

Location

Severance Hospital

Seoul, South Korea

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lynnett Voshage-Stahl

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 30, 2013
• Study Start: January 13, 2014
• Primary Completion: January 23, 2018
• Study Completion: March 31, 2019
• Last Updated: August 21, 2019

Record last verified: 2017-06

Locations

KR (1); HK (1); TH (1); AU (3); ID (1); MY (1); SA (1)