NCT03816410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2015

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2015

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

January 22, 2019

Last Update Submit

January 22, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Serum levels of proANP and BNP until 800days post surgery

    800days

Study Arms (2)

LAA amputation group

EXPERIMENTAL
Procedure: LAA amputation

No LAA amputation group

NO INTERVENTION

Interventions

LAA amputationPROCEDURE

complete surgical amputation of the left atrial appendage

LAA amputation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Adult and Pediatric Cardiovascular Surgery

Giessen, 35392, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 1:1 Randomization
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 25, 2019

Study Start

May 1, 2015

Primary Completion

October 30, 2015

Study Completion

December 1, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)