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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WATCHMAN LAA Closure Technology (Gen 4.0)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Stroke, Warfarin, Coumadin, TIA, Trans Ischemic Attack

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NA Homolce Hospital
  • Krankenhaus der Barmherzige Bruder
  • Sankt Katharinen Hospital / Cardiovasculares Centrum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantable device

Arm Description

WATCHMAN LAA Closure Technology (Gen 4.0)

Outcomes

Primary Outcome Measures

Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
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.
Device Success
Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2010
Last Updated
December 7, 2015
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01196897
Brief Title
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
Acronym
EVOLVE
Official Title
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Stroke, Warfarin, Coumadin, TIA, Trans Ischemic Attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implantable device
Arm Type
Experimental
Arm Description
WATCHMAN LAA Closure Technology (Gen 4.0)
Intervention Type
Device
Intervention Name(s)
WATCHMAN LAA Closure Technology (Gen 4.0)
Intervention Description
Implantation of the WATCHMAN device into the left atrial appendage.
Primary Outcome Measure Information:
Title
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
Description
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.
Time Frame
12-Months
Title
Device Success
Description
Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
Time Frame
Implant through 45-Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Na Homolce Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NA Homolce Hospital
City
Prague
ZIP/Postal Code
150 30
Country
Czech Republic
Facility Name
Krankenhaus der Barmherzige Bruder
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93049
Country
Germany
Facility Name
Sankt Katharinen Hospital / Cardiovasculares Centrum
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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