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

NCT01196897 | Completed DMC

• 1 other identifier: CT1000
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 3

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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Implantable device

EXPERIMENTAL

WATCHMAN LAA Closure Technology (Gen 4.0)

Device: WATCHMAN LAA Closure Technology (Gen 4.0)

Interventions

WATCHMAN LAA Closure Technology (Gen 4.0) DEVICE

Implantation of the WATCHMAN device into the left atrial appendage.

Implantable device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

NA Homolce Hospital

Prague, 150 30, Czechia

Location

Krankenhaus der Barmherzige Bruder

Regensburg, Bavaria, 93049, Germany

Location

Sankt Katharinen Hospital / Cardiovasculares Centrum

Frankfurt, 60389, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Vivek Reddy, MD

  Na Homolce Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: September 9, 2010
• Study Start: May 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2013
• Last Updated: December 8, 2015

Record last verified: 2012-08

Locations

DE (2); CZ (1)