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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Atritech

ClinicalTrials.gov Identifier:

NCT01196897

First received: August 16, 2010

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 16, 2010
Last Updated Date	August 1, 2012
Start Date ^ICMJE	May 2009
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 8, 2010)	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 ] [ Designated as safety issue: Yes ] 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 [ Time Frame: Implant through 45-Days ] [ Designated as safety issue: No ] Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01196897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
Official Title ^ICMJE	Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Atrial Fibrillation
Intervention ^ICMJE	Device: WATCHMAN LAA Closure Technology Implantation of the WATCHMAN device into the left atrial appendage.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Czech Republic, Germany

Administrative Information
NCT Number ^ICMJE	NCT01196897
Other Study ID Numbers ^ICMJE	CT1000
Has Data Monitoring Committee	Yes
Responsible Party	Atritech
Study Sponsor ^ICMJE	Atritech
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Atritech
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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