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WATCHMAN Implantation During Hybrid Ablation

NCT02471131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-01-11

No results posted yet for this study

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality. The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular AF. The WATCHMAN™ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with epicardial devices is known to be difficult and not free of risks.It thus will be interesting to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid ablation approach.

Conditions

Interventions

DEVICE

WATCHMAN Device implantation

The implantation of the device will be done into the left atrial appendage according to the guidelines.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Laurent Pison, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471131 on ClinicalTrials.gov