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

Atrial Fibrillation Clinical Trial

— EVOLVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196897
• Other study ID #: CT1000
• Status: Completed
• Phase: N/A
• First received: August 16, 2010
• Last updated: December 7, 2015
• Start date: May 2009
• Est. completion date: November 2013

Study information

• Verified date: August 2012
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• WATCHMAN LAA Closure Technology (Gen 4.0)
Implantation of the WATCHMAN device into the left atrial appendage.

Locations

Country	Name	City	State
Czech Republic	NA Homolce Hospital	Prague
Germany	Sankt Katharinen Hospital / Cardiovasculares Centrum	Frankfurt
Germany	Krankenhaus der Barmherzige Bruder	Regensburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12-Months	Yes
Primary	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.	Implant through 45-Days	No