Natriuretic Peptides After Left Atrial Appendage Amputation

NCT ID: NCT03816410

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2018-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 Randomization
Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LAA amputation group

Group Type EXPERIMENTAL

LAA amputation

Intervention Type PROCEDURE

complete surgical amputation of the left atrial appendage

No LAA amputation group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LAA amputation

complete surgical amputation of the left atrial appendage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

* Lack of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Adult and Pediatric Cardiovascular Surgery

Giessen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SR-345-DP

Identifier Type: -

Identifier Source: org_study_id

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