Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE) (EVOLVE)

December 7, 2015 updated by: Boston Scientific Corporation

Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients

This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 150 30
        • Na Homolce Hospital
  • Germany
      • Frankfurt, Germany, 60389
        • Sankt Katharinen Hospital / Cardiovasculares Centrum
    • Bayern
      • Regensburg, Bayern, Germany, 93049
        • Krankenhaus der Barmherzige Bruder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
  • Eligible for long-term Warfarin therapy;
  • Eligible to come off Warfarin therapy if the LAA is sealed
  • Calculated CHADS2 score of 1 or greater

Key Exclusion Criteria:

  • New York Heart Association Class IV Congestive Heart Failure
  • Recent MI (within 3 months)
  • ASD and/or atrial septal repair or closure device
  • Resting heart rate >110 bpm
  • Has an implanted mechanical valve prosthesis
  • Left atrial appendage is obliterated
  • Has undergone heart transplantation
  • Has symptomatic carotid disease
  • Contraindicated for aspirin
  • LVEF < 30%
  • Cardiac Tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implantable device
WATCHMAN LAA Closure Technology (Gen 4.0)
Device: WATCHMAN LAA Closure Technology (Gen 4.0)
Implantation of the WATCHMAN device into the left atrial appendage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
Time Frame: 12-Months
The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure.
12-Months
Device Success
Time Frame: Implant through 45-Days
Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
Implant through 45-Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Vivek Reddy, MD, Na Homolce Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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