Safety and Effectiveness of Left Atrial Appendage Occlusion

NCT00567515 | Completed Phase 2 DMC

• 1 other identifier: OUS 2007-1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Safety - Device related complications

  30 days

• Efficacy - Occlusion of the LAA

  6 months

Study Arms (1)

LAA Clip

EXPERIMENTAL

AtriCure LAA Exclusion System

Device: AtriCure LAA Exclusion System

Interventions

AtriCure LAA Exclusion System DEVICE

Placement of clip of LAA.

LAA Clip

Eligibility Criteria

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

You may qualify if:

• Documented history (paroxysmal, persistent or permanent) of AF \[one episode within the last 12 months of enrollment\]
• Elective Maze procedure
• Suitable anatomy
• Able and willing to sign informed consent
• Age over 18 years

You may not qualify if:

• Patient from Intensive Care Unit with either:
• intra-venous catecholamines
• ventilator
• cardiac index \<1.8 l/min.
• Reoperative Cardiac Surgery
• Systemic or Inflammatory disease
• Dialysis
• Recent myocardial infarction (\< 21 days)
• History of pericarditis
• Patient taking part in any other device or drug study
• Patient with known sensitivity or allergy to any of the device components
• Pregnancy

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (1)

University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (3)

• Caliskan E, Sahin A, Yilmaz M, Seifert B, Hinzpeter R, Alkadhi H, Cox JL, Holubec T, Reser D, Falk V, Grunenfelder J, Genoni M, Maisano F, Salzberg SP, Emmert MY. Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. Europace. 2018 Jul 1;20(7):e105-e114. doi: 10.1093/europace/eux211.

  PMID: 29016813 DERIVED

• Emmert MY, Puippe G, Baumuller S, Alkadhi H, Landmesser U, Plass A, Bettex D, Scherman J, Grunenfelder J, Genoni M, Falk V, Salzberg SP. Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial. Eur J Cardiothorac Surg. 2014 Jan;45(1):126-31. doi: 10.1093/ejcts/ezt204. Epub 2013 May 8.

  PMID: 23657550 DERIVED

• Salzberg SP, Plass A, Emmert MY, Desbiolles L, Alkadhi H, Grunenfelder J, Genoni M. Left atrial appendage clip occlusion: early clinical results. J Thorac Cardiovasc Surg. 2010 May;139(5):1269-74. doi: 10.1016/j.jtcvs.2009.06.033. Epub 2009 Nov 1.

  PMID: 19880144 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Genoni, MD, Professor

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

CH (1)