NCT00851578

Brief Summary

The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 27, 2015

Status Verified

September 1, 2013

Enrollment Period

3.1 years

First QC Date

February 24, 2009

Last Update Submit

January 26, 2015

Conditions

Atrial Fibrillation

Keywords

AFatrial fibrillationLAA occlusion

Outcome Measures

Primary Outcomes (1)

  • Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment

    2 years

Study Arms (1)

WATCHMAN

EXPERIMENTAL

non-valvular atrial fibrillation patients contraindicated to warfarin

Device: WATCHMAN

Interventions

WATCHMANDEVICE

WATCHMAN LAA Closure Device

WATCHMAN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • paroxysma, persistent, or permanent non-vlavular atrial fibrillation
  • contraindicated to warfarin
  • eligible for clopidogrel, ticlopdine, heparin, or aspirin
  • CHADS score 1 or greater

You may not qualify if:

  • NYHA Class IV
  • LAA obliteration
  • Heart transplant
  • LVEF less than 30%
  • greater than 50% carotid stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NA Homolce Hospital

Prague, 150 30, Czechia

Location

Sankt Katharinen Hospital / Cardiovasculares Centrum

Frankfurt, 60389, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Chefarzt der Medizinischen Klinik III/Kardiologie

Regensburg, 93049, Germany

Location

Related Publications (1)

  • Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.

    PMID: 23583249DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vivek Reddy, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 26, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2012

Study Completion

December 1, 2013

Last Updated

January 27, 2015

Record last verified: 2013-09

Locations

DE(3)CZ(1)