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BEST-CLOSURE BErlinSTeglitz- Cerebral Lesions after left atrial appendage clOSURE

Organizational Data

DRKS-ID:
DRKS00010300
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2016-04-18
Last update in DRKS:
2017-12-05
Registration type:
Prospective

Acronym/abbreviation of the study

BEST Closure

URL of the study

No Entry

Brief summary in lay language

The study is the risk stratification and the improvement of security relating to thromboembolic events in the context of atrial appendage occlusion in patients with atrial fibrillation. Due to the frequency of use of atrial appendage closures worldwide in the treatment of atrial fibrillation, the test results may be for a variety of patients is important.

Brief summary in scientific language

Objective of this study is to evaluate the incidence of clinically silent cerebral lesions (SCL) in patients with atrial fibrillation (AF) after atrial appendage closure (VOV). To detect these Events, before and after VOV, a MRI of the head as well as the implementation of the MoCA test had taken place. In addition, a follow up is planned after 2 weeks and a clinical follow-up after three months.

Health condition or problem studied

Free text:
silent cerebral lesions
Free text:
Impairment of cognitive performance after VOV
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
MRI of the head as well as the implementation of the MoCA test before and after the VOV- intervention had taken place, follow-up after 2 weeks, clinical follow-up after three months. The first MRI takes place immediately before VOV. The second within 48h after VOV.

Endpoints

Primary outcome:
Detection of silent cerebral lesions on MRI of the head before and after atrial appendage closure (VOV). The first MRI is performed immediately prior to VOV. The second cerebral MRI within 48h after VOV. The primary endpoint is reached when new cerebral lesions are visible on MRI after VOV.
Secondary outcome:
Impairment of cognitive performance with neurocognitive questionnaire (MOCA) test before and after left atrial appendage occlusion. The secondary endpoint is achieved when there is a deterioration of MOCA test. The first MOCA test is performed immediately prior to VOV. The Second within 48h after VOV.

Study Design

Purpose:
Prevention
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Berlin

Recruitment period and number of participants

Planned study start date:
2016-04-20
Actual study start date:
2016-04-20
Planned study completion date:
No Entry
Actual Study Completion Date:
2017-05-09
Target Sample Size:
25
Final Sample Size:
25

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
There are both women (after exclusion of pregnancy), and men who are over 18 years old, included with atrial fibrillation and atrial appendage closure planned. There must be no contraindications for MRI. Consent for study participation.

Exclusion Criteria

Pregnancy. Neurological event within 3 months prior to the atrial appendage closure.

Addresses

Primary Sponsor

Charite Berlin
Dr. Barbara Bellmann
Hindenburgdamm 30
12203 Berlin
Germany
Telephone:
030 450513826
Fax:
03045013825
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Charite Berlin Abteilung für Kardiologie Campus Benjamin Franklin
Dr. med. Barbara Bellmann
Hindenburgdamm 30
12003 Berlin
Germany
Telephone:
030450513847
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Charite Berlin Abteilung für Kardiologie Campus Benjamin Franklin
Dr. Barbara Bellmann
Hindeburgdamm 30
12203 Berlin
Germany
Telephone:
030450513847
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Charite Berlin Abteilung für Kardiologie Campus Benjamin Franklin
Dr. med. Barbara Bellmann
Hindenburgdamm 30
12003 Berlin
Germany
Telephone:
030450513847
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Charite Berlin Abteilung für Kardiologie Campus Benjamin Franklin
Hindenburgdamm 30
12003 Berlin
Germany
Telephone:
030450513847
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Charité – Universitätsmedizin Berlin
Charitéplatz 1
10117 Berlin
Germany
Telephone:
(+49)30-450517222
Fax:
(+49)30-450517952
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2015-09-09
Ethics committee number:
EA 4/084/15
Vote of the Ethics Committee:
Approved
Date of the vote:
2015-09-18

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry