Back to resultsNatriuretic Peptides After Left Atrial Appendage Amputation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
LAA amputation
Sponsored by
About this trial
This is an interventional screening trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
- Lack of informed consent
Sites / Locations
- Department of Adult and Pediatric Cardiovascular Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LAA amputation group
No LAA amputation group
Arm Description
Outcomes
Primary Outcome Measures
Serum levels of proANP and BNP until 800days post surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT03816410
First Posted
January 22, 2019
Last Updated
January 22, 2019
Sponsor
University of Giessen
1. Study Identification
Unique Protocol Identification Number
NCT03816410
Brief Title
Natriuretic Peptides After Left Atrial Appendage Amputation
Official Title
Influence of Left Atrial Appendage Amputation on Natriuretic Peptides - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
October 30, 2015 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Giessen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Surgical amputation of the left atrial appendage (LAA) is an established intervention during surgical atrial fibrillation (AF) therapy. However, its effects on the endocrine function of the left atrium are unclear. This study aims to quantify the serum levels of natriuretic peptides in patients who undergo concomitant surgical AF ablation with or without LAA amputation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 Randomization
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAA amputation group
Arm Type
Experimental
Arm Title
No LAA amputation group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
LAA amputation
Intervention Description
complete surgical amputation of the left atrial appendage
Primary Outcome Measure Information:
Title
Serum levels of proANP and BNP until 800days post surgery
Time Frame
800days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
Lack of informed consent
Facility Information:
Facility Name
Department of Adult and Pediatric Cardiovascular Surgery
City
Giessen
ZIP/Postal Code
35392
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Natriuretic Peptides After Left Atrial Appendage Amputation
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