Left Atrial Appendage Occlusion and Biomarker Evaluation

NCT02985463 | Unknown

• 1 other identifier: 2014-402M-MA-§ 23b MPG
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (LAA) occlusion device at mid-term follow-up.

Conditions

Stroke; Atrial Fibrillation; Bleeding

Outcome Measures

Primary Outcomes (1)

• Biomarker levels before successful LAA occlusion device implantation

  24 hours before intervention

Secondary Outcomes (2)

• Biomarker levels after successful LAA occlusion device implantation

  mid-term follow up at 6 months

• Changes of biomarker expression before and after device implantation over mid-term follow-up, depending of complete, incomplete occlusion, imaging data (transesophageal echocardiography, computed tomography)

  mid-term follow up at 6 months

Eligibility Criteria

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

Study Population

Patients suffering from non valvular atrial fibrillation with a contraindication for oral anticoagulation (i.e. bleeding) being eligible of percutaneous implantation of LAA occlusion devices.

You may qualify if:

• non valvular atrial fibrillation, that makes anticoagulation to prevent embolic stroke from the LAA
• contraindication for the therapy with oral anticoagulants:
• refusal to take oral anticoagulation
• HasBled-score more than 3
• prior bleedings under oral anticoagulation

You may not qualify if:

• under 18 years
• severely reduced left atrial function
• mechanical heart valve
• pulmonary embolism
• deep vein thrombosis
• myocardial infarction within the last 3 months
• electrical cardioversion within 30 days after potential occluder implantation
• atrial septum defect or interventional/surgical occlusion of ASD
• status after heart transplant
• symptomatic carotid artery stenosis
• transient ischemic attack (TIA) or stroke within last 30 days
• intracerebral bleeding within the last 2 months
• acute infection
• existing or planned pregnancy

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

University Medical Centre Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (4)

• Behnes M, Akin I, Sartorius B, Fastner C, El-Battrawy I, Borggrefe M, Haubenreisser H, Meyer M, Schoenberg SO, Henzler T. --LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography. BMC Med Imaging. 2016 Mar 24;16:25. doi: 10.1186/s12880-016-0127-y.

  PMID: 27009279 BACKGROUND

• Fastner C, Behnes M, Sartorius B, Yildiz M, Mashayekhi K, El-Battrawy I, Lehmann R, Baumann S, Becher T, Borggrefe M, Akin I. Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study. BMC Cardiovasc Disord. 2016 Jan 28;16:25. doi: 10.1186/s12872-016-0200-z.

  PMID: 26822890 RESULT

• Rusnak J, Behnes M, Saleh A, Fastner C, Sattler K, Barth C, Wenke A, Sartorius B, Mashayekhi K, Hoffmann U, Yuecel G, Lang S, Borggrefe M, Akin I. Interventional left atrial appendage closure may affect metabolism of essential amino acids and bioenergetic efficacy. Int J Cardiol. 2018 Oct 1;268:125-131. doi: 10.1016/j.ijcard.2018.05.031. Epub 2018 Jun 1.

  PMID: 29861102 DERIVED

• Fastner C, Behnes M, Sartorius B, Wenke A, Lang S, Yucel G, Sattler K, Rusnak J, Saleh A, Barth C, Mashayekhi K, Hoffmann U, Borggrefe M, Akin I. Interventional Left Atrial Appendage Closure Affects the Metabolism of Acylcarnitines. Int J Mol Sci. 2018 Feb 7;19(2):500. doi: 10.3390/ijms19020500.

  PMID: 29414920 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Two peripheral blood withdraws in EDTA, citrate, ammonium heparin, serum tubes 24 hours before and at mid-term follow up at 6 months after successful LAA occlusion device implantation.

MeSH Terms

Conditions

Stroke; Atrial Fibrillation; Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Ibrahim Akin, Prof.

  University Medical Center Mannheim

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 7, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)