Cardioblate Closure Device Closed Thorax Trial:An Evaluation of the Cardioblate® Closure* Device in Facilitating Occlusion of the Left Atrial Appendage in Closed Thorax Surgeries

Withdrawn

• Conditions: cardiac rhythm disorders; heart failure; 10007521

• Registration Number: NL-OMON33336
• Lead Sponsor: Cardiovascular Department SHD/RST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Subjects who meet the following criteria should be considered for the study:
1) >18 and < 80 years of age
2) Concomitant indication for closed thorax cardiac surgery for one or more of the following:
a. Mitral valve repair or replacement
b. Aortic valve repair or replacement
c. Tricuspid valve repair or replacement
d. CABG for subjects >60 years of age
e. CABG for subjects <60 years of age with a history of AF
f. Surgical ablation or Maze procedure
3) The subject is willing and able to provide written informed consent and comply with study requirements

Exclusion Criteria

Subjects who meet any of the following criteria should not be considered for the study:
1) Thrombus in LAA and/or LA
2) Prior LAA isolation attempt(s)
3) Patient is contraindicated for an intra-operative transesophageal echocardiogram (TEE)
4) Unable to take an anticoagulant during the study follow-up period
5) Subject is undergoing an emergency cardiac procedure
6) Life expectancy of less than 12 months
7) Pregnancy or desire to be pregnant within 12 months of the study procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified