NCT06707506

Brief Summary

This retrospective cohort study investigates how CT-derived tissue quality parameters, serving as markers of metabolic status, predict post-operative atrial fibrillation risk in patients undergoing minimally invasive mitral valve surgery. The study leverages established associations between adipose tissue characteristics and metabolic dysfunction to explore their potential role in post-surgical arrhythmogenesis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

January 1, 2014

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

9.9 years

First QC Date

November 24, 2024

Last Update Submit

November 24, 2024

Conditions

Mitral RegurgitationComputed TomographyAtrial Fibrillation

Keywords

Post-operative Atrial FibrillationBody CompositionComputed TomographyMitral Valve SurgeryMetabolic Risk Factors

Outcome Measures

Primary Outcomes (1)

  • postoperative atrial fibrillation development

    Defined as new-onset AF lasting more than 48 hours or requiring intervention Measured through continuous cardiac monitoring Analyzed separately for patients with and without preoperative AF history

    Through August 1, 2024

Secondary Outcomes (2)

  • Overall Survival

    Through August 1, 2024

  • Perioperative Complications

    Through August 1, 2024

Eligibility Criteria

Age19 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This single-center retrospective cohort study included 114 consecutive patients who underwent minimally invasive mitral valve surgery between January 2014 and November 2023 at the Complex Cardiovascular Center, Hospital AGEL Trinec-Podlesi.

You may qualify if:

  • Age ≥ 18 years
  • Undergoing minimally invasive mitral valve surgery
  • Preoperative CT scan available
  • Surgery between January 2014 and November 2023

You may not qualify if:

  • Incomplete clinical data
  • Poor quality CT images
  • Previous cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mitral Valve InsufficiencyAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Matej Pekar, MD, PhD

Study Record Dates

First Submitted

November 24, 2024

First Posted

November 27, 2024

Study Start

January 1, 2014

Primary Completion

November 30, 2023

Study Completion

August 1, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11