Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease

NCT04525339 | Unknown

• 1 other identifier: TAVI & OPCAB
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.

• Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG
• Objective3:Assess early 3 months outcomes and postoperative results Outcome Measure: 1\. All-cause mortality within 3 months. Secondary Outcome Measures:
• Stroke
• Myocardial infarction
• Bleeding
• Hospital stay
• Acute kidney injury
• Number of patients with conduction disturbance and pacemaker implantation
• Gradient on implanted valve
• Degree of transvalvular leakage
• 6 weeks follow-up
• 3 months Echo

Conditions

Aortic Valve Disease; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  3 months

Secondary Outcomes (8)

• Occurence of Stroke

  I month

• Occurence of Myocardial infarction

  I month

• Need for reexploration

  I month

• Occurence of Acute kidney injury

  I month

• Number of patients with conduction disturbance and pacemaker implantation

  I month

Interventions

TAVI and Off pump CABG PROCEDURE

Concomitant Transcatheter aortic valve implanatation and off pump coronary artery bypass grafting

Eligibility Criteria

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

Study Population

All patients registered in cardiac surgery department, Manchester Royal Infirnary in the last five years 2015 till 2020, and who meet the listed inclusion and exclusion criteria will be eligible for the study.

You may qualify if:

• Patients with severe symptomatic aortic stenosis and CAD undergoing TAVI \& OPCABG

You may not qualify if:

• Patients with concomitant valvular heart disease.

Sponsors & Collaborators

• Assiut University: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Aortic Valve Disease; Coronary Artery Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Cardiothoracic Surgery/ Principle Investigator

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 25, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: August 1, 2021
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

EG (1)