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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01196897

Acronym

EVOLVE

Enrollment

Registered

2010-09-09

Start date

2009-05-31

Completion date

2013-11-30

Last updated

2015-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Stroke, Warfarin, Coumadin, TIA, Trans Ischemic Attack

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.

Interventions

DEVICEWATCHMAN LAA Closure Technology (Gen 4.0)

Implantation of the WATCHMAN device into the left atrial appendage.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Czechia, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026