Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation

NCT02105584 | Completed DMC

• 2 other identifiers: OCC201202CIV-13-09-011614
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 7

Brief Summary

This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.

  A major complication is defined as an event that results in death, procedure related stroke, systemic embolism, device embolisation, pericardial effusion (cardiac tamponade), or other major bleeding requiring invasive treatment or blood transfusions.

  12 months

Study Arms (1)

LAA closure device

EXPERIMENTAL

Implantation of LAA closure device

Device: Implantation of LAA closure device

Interventions

Implantation of LAA closure device DEVICE

Also known as: Occlutech LAA occluder in different sizes

LAA closure device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented paroxysmal, persistent or chronic non-valvular AF
• Calculated CHA2DS2 -VASC score equal or greater than 2 and/or HAS-BLED score equal or greater than 2
• Patients eligible or non-eligible for lifelong, oral anticoagulation therapy
• Life expectancy of at least 1 year
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

You may not qualify if:

• Suspected or known intracardiac thrombus
• NYHA Class IV CHF
• Patients who has unstable and intractable angina pectoris
• ASD and/or atrial septal repair or closure device
• Recent myocardial infarction within 3 months
• Severe valvular heart disease, or implanted mechanical valve prosthesis
• Large PFO with significant atrial septal aneurysm
• Planned ablation procedure within 30 days of Occlutech LAA occluder® implant
• Resting heart rate \> 110 bpm
• Allergy to Nitinol, which is a result of nickel and/or titanium allergies
• Stroke/TIA within the last 30 days
• Thrombocytopenia, thrombocytosis, leukopenia, or anemia
• Symptomatic carotid artery disease
• LVEF \< 30%
• Mitral valve stenosis

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (7)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Kardiologie Universitätsklinikum Bonn

Bonn, Germany

Location

Medizinische Klinikum Coburg

Coburg, 96450, Germany

Location

CardioVascular Center Frankfurt

Frankfurt, Germany

Location

Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

University Medical Center of Johannes Gutenberg-University Mainz

Mainz, Germany

Location

NHS Trust (ICHNT) Hammersmith Hospital London

London, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Johannes Brachmann, Prof

  Klinikum Coburg

  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: March 27, 2014
• First Posted: April 7, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

GB (1); DE (6)