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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: WATCHMAN LAA Closure Technology (Gen 4.0)

• Registration Number: NCT01196897
• Lead Sponsor: Boston Scientific Corporation

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 available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Status Verified: 2012-08
• Primary Completion: 2012-09
• Study Completion: 2013-11
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantable device	WATCHMAN LAA Closure Technology (Gen 4.0)	WATCHMAN LAA Closure Technology (Gen 4.0)

Primary Outcome Measures

Name	Time	Method
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.	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.
Device Success	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.

Trial Locations

Locations (3)

NA Homolce Hospital; 🇨🇿 Prague, Czech Republic

Krankenhaus der Barmherzige Bruder; 🇩🇪 Regensburg, Bayern, Germany

Sankt Katharinen Hospital / Cardiovasculares Centrum; 🇩🇪 Frankfurt, Germany