Status:
COMPLETED
Personalised Decision Support for Heart Valve Disease
Lead Sponsor:
German Heart Institute
Collaborating Sponsors:
University of Sheffield
Ansys SAS
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Valvular Heart Disease currently affects 2.5% of the population, but is overwhelmingly a disease of the elderly and consequently on the rise. It is dominated by two conditions, Aortic Stenosis and Mit...
Detailed Description
Study design: In the study a Decision Support System for aortic and mitral valve replacement/repair will be implemented and tested. Not all of the assessments listed will be performed on every patien...
Eligibility Criteria
Inclusion
- The patient must give Informed Consent before being enrolled in the study.
- Only elective cases will be eligible for inclusion. For mitral disease, patients were recruited with;
- Severe degenerative or functional mitral regurgitation with the need for MVR according to the ESC/EACTS guidelines.
- Degenerative mitral regurgitation
- symptomatic patients with LVEF \>30% and LVESD \< 55mm (I B)
- asymptomatic patients with LV dysfunction (LVESD ≥45 mm and/or LVEF ≤60% (I C)
- asymptomatic patients with LVEF \> 50%, new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure at rest \>50 mmHg) (IIa C)
- patients with severe LV dysfunction (LVEF \< 30% and LVESD \> 55 mm) refractory to medical therapy with high likelihood of durable repair and low comorbidity. (IIa C) Functional mitral regurgitation
- patients with severe MR (EROA \>= 20 mm², Regurgitation volume \> 30 ml) undergoing CABG, and LVEF \>30% (I C)
- patients with moderate MR undergoing CABG (IIa C)
- symptomatic patients with severe MR, LVEF \< 30 %, option for revascularisation, and evidence of viability (IIa C) For aortic valve disease, patients will be recruited with;
- Severe acquired degenerative aortic valve disease with the need for SAVR or TAVI according to the ESC/EACTS guidelines Severe Aortic stenosis
- symptomatic patients (I B)
- patients undergoing CABG or surgery of ascending aorta or another valve (I C)
- asymptomatic patients with abnormal exercise test (I C) / LVEF \< 50% (I C) / blood pressure drop on exercise / peak gradient \> 5.5 m/sec ( (IIa C)
- symptomatic patients with low flow, low gradient (\< 40mmHg) and normal LVEF (IIa C)
Exclusion
- Inability or unwillingness to give formal consent.
- Emergency interventions
- Active infective valvular disease or evidence of valvular damage by recent endocarditis
- Valvular malfunction directly associated with aortic root disease
- Aortic regurgitation as leading aortic valve pathology
- Inability or unwillingness to complete follow up
- MRI contraindications (Implanted pacemaker, Metallic foreign body, Severe claustrophobia)
- CT contraindications (Known iodine or contrast agent allergy, Hyperhidrosis, Pregnancy)
Key Trial Info
Start Date :
January 20 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04068740
Start Date
January 20 2016
End Date
January 31 2019
Last Update
August 28 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.