Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device

NCT03339193 | Withdrawn

• 1 other identifier: PID11776
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and with contraindications to long-term oral antocoagulation therapy.

Conditions

Atrial Fibrillation; Stroke

Keywords

atrial fibrillation; stroke; atrial appendage

Outcome Measures

Primary Outcomes (2)

• Procedural success rates, (redeployments and devices used)

  Implant characteristics. This is a descriptive study

  Implant procedure

• Procedural characteristics (including number of repositions),

  Implant characteristics. This is a descriptive study

  Implant procedure

Secondary Outcomes (1)

• Procedure complications

  Implant procedure

Study Arms (1)

Patients having LAAC

Patients who meet current clinical criteria for left atrial appendage closure (LAAC), ie have atrial fibrillation, a CHA2DS2-VASc score of 3 or more and a contraindication to long-term oral anticoagulation therapy and who have been approved by the OUH NHS Foundation Trust LAAC Multidisciplinary Team (MDT) as suitable for left atrial appendage occlusion in accordance with National Health Service (NHS) guidelines.

Device: Left atrial appendage closure

Interventions

Left atrial appendage closure DEVICE

Percutaneous insertion of a Watchman FLX left atrial appendage closure device under general anesthesia with transesophageal echo guidance.

Patients having LAAC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective left atrial appendage occlusion/closure in accordance with UK guidelines

You may not qualify if:

• Subjects who are eligible for a WATCHMAN FLX device per physician discretion according to current international and local guidelines and currently approved indications
• Subjects who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre
• Subjects whose age is 18 years or above, or of legal age to give informed consent specific to national law.
• Subjects 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.
• Subjects who are unable or not willing to complete the follow-up visits and examination at 6 weeks.
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
• Documented life expectancy of less than 12 months.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Department of Cardiology, John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Left Atrial Appendage Closure

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)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Tim Betts, MD

  Oxford University Hospitals NHS Trust

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: November 13, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 13, 2017

Record last verified: 2017-03

Locations

GB (1)