Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI

NCT04385459 | Completed

• 1 other identifier: 273468
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Keywords

Aortic valve stenosis; Coronary artery disease; Transcatheter aortic valve implantation; Mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death after the procedure

  Five years.

Secondary Outcomes (1)

• Factors associated with less favorable early and late mortality

  Five years

Study Arms (2)

Patients without coronary artery disease

No prior coronary intervention and no significant stenosis noted during coronary angiography.

Patients with coronary artery disease

Our definition of coronary artery disease is: * Prior coronary artery bypass grafting or percutaneous coronary intervention * Significant stenosis or occlusion noted during coronary angiography

Other: Coronary artery disease

Interventions

Coronary artery disease OTHER

Exposure

Patients with coronary artery disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that underwent a TAVI procedure at Örebro University Hospital between the time period 2009 till 1st december 2019 were included.

You may qualify if:

• All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019.

You may not qualify if:

• Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.

Sponsors & Collaborators

• Örebro County Council: lead

Study Sites (1)

Department for Cardiothoracic and Vascular Surgery, Örebro University Hospital

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Interventions

JCAD protein, mouse

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ninos Samano, MD,PhD

  Department of Cardiothoracic and Vascular Surgery, Örebro University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 13, 2020
• Study Start: December 13, 2018
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

SE (1)