- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03816410
Natriuretic Peptides After Left Atrial Appendage Amputation
January 22, 2019 updated by: University of Giessen
Influence of Left Atrial Appendage Amputation on Natriuretic Peptides - a Randomized Controlled Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Giessen, Germany, 35392
- Department of Adult and Pediatric Cardiovascular Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
- Lack of informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LAA amputation group
|
complete surgical amputation of the left atrial appendage
|
No Intervention: No LAA amputation group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum levels of proANP and BNP until 800days post surgery
Time Frame: 800days
|
800days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
October 30, 2015
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
January 22, 2019
First Submitted That Met QC Criteria
January 22, 2019
First Posted (Actual)
January 25, 2019
Study Record Updates
Last Update Posted (Actual)
January 25, 2019
Last Update Submitted That Met QC Criteria
January 22, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SR-345-DP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
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Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
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Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
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Beijing Anzhen HospitalJohnson & Johnson; Heart Health Research CenterNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
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Maastricht UniversityRadboud University Medical Center; Maastricht University Medical CenterRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Atrial Fibrillation ParoxysmalNetherlands
Clinical Trials on LAA amputation
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Brigham and Women's HospitalEnrolling by invitationLower Extremity Amputation | Trans-Tibial Amputation | Traumatic Lower Extremity Amputation | Agonist-Antagonist Myoneural InterfaceUnited States
-
Brigham and Women's HospitalMassachusetts General Hospital; Massachusetts Institute of Technology; Walter...Recruiting
-
Boston Scientific CorporationWithdrawn
-
Assiut UniversityNot yet recruiting
-
Massachusetts Institute of TechnologyEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingAmputationUnited States
-
AtriCure, Inc.Completed
-
MedianOtto Bock Healthcare Products GmbH; University Medical Center MainzRecruitingTransfemoral AmputationGermany
-
Jonas MalmstedtCompletedQuality of Life | Peripheral Arterial Disease | Amputation | Prosthesis UserSweden
-
Cardia Inc.UnknownNon-Valvular Atrial Fibrillation | Left Atrial AppendageCanada
-
Helsinki University Central HospitalWithdrawnDiabetes Complications | AmputeesFinland