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Completed

NCT Number: NCT01196897

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NA Homolce Hospital, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WATCHMAN LAA Closure Technology (Gen 4.0)

Device

Implantation of the WATCHMAN device into the left atrial appendage.

Primary outcomes

  1. 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

    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.

  2. Device Success

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: EVOLVE

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Sep 9, 2010
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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