Better Patient Selection to Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

Official title:

Better Patient Selection to Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107923
• Other study ID #: 535444
• Status: Completed
• Start date: April 26, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

Description:

In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.

Exclusion Criteria:

• Aortic valve endocarditis
• aortic annulus >31mm
• preoperative pacemaker
• severe aortic insufficiency (>grad 3)
• rapid atrial fibrillation
• unprotected left main coronary stenosis not suitable for percutaneous intervention.
• unstable angina
• life expectancy less than 12 months
• mental disorder including dementia and condition which interferes with protocol compliance.
• renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI.
• Patients with metal not suitable for MRI.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Fibrosis
• Left Ventricular Dysfunction
• Myocardial Fibrosis
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Diagnostic Test:
• Dobutamine stress test
Test of myocardial reserve

Locations

Country	Name	City	State
Norway	Oslo Universtity Hospital	Oslo
Norway	The Intervention Centre	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Bax JJ, Delgado V, Bapat V, Baumgartner H, Collet JP, Erbel R, Hamm C, Kappetein AP, Leipsic J, Leon MB, MacCarthy P, Piazza N, Pibarot P, Roberts WC, Rodes-Cabau J, Serruys PW, Thomas M, Vahanian A, Webb J, Zamorano JL, Windecker S. Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation. Eur Heart J. 2014 Oct 7;35(38):2627-38. doi: 10.1093/eurheartj/ehu256. Epub 2014 Jul 25. — View Citation

Eidet J, Dahle G, Bugge JF, Bendz B, Rein KA, Aaberge L, Offstad JT, Fosse E, Aakhus S, Halvorsen PS. Long-term outcomes after transcatheter aortic valve implantation: the impact of intraoperative tissue Doppler echocardiography. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):403-9. doi: 10.1093/icvts/ivw159. Epub 2016 May 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	MACE at 12 months follow-up after TAVI, MACE definition: rehospitalization for heart failure or other valve related complications, nonfatal myocardial infarction, nonfatal stroke, or (cardiovascular) death	1 year
Secondary	NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome	Number of Participants hospitalizated for heart related diseases during 12 month follow-up.	1 year
Secondary	Patient quality of life (QoL)	Quality of life record (SF 36), Physical function (age adjusted normal value 71.6 (SD 26.9)) and Physical role (age adjusted normal value 57.0 (SD 43.8)) , the patients were divided into groups using the predefined minimal change of 15 and 18,75 points, respectively. Changes above these tresholds at 12 month follow-up indicat better QoL outcomes.	1 year
Secondary	6 Minute Walking Test	Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up.	1 year