Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis

NCT05133843 | Recruiting

• 1 other identifier: 2021-0125
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.

Conditions

Coronary Artery Stenosis; Transcatheter Aortic Valve Implantation

Keywords

Coronary Artery Stenosis; transcatheter aortic valve implantation; coronary physiology; coronary blood flow; coronary microcirculatory function; non-invasive CT-FFR; fractional flow reserve; resting full cycle ratio

Outcome Measures

Primary Outcomes (1)

• Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI

  Comparison of coronary flow reserve, index of microvascular resistance, fractional flow reserve and resting full cycle ratio. The variation in correlation between CT-FFR and IMR, FFR or RFR before and after TAVI will be estimated using a General Linear Model (GLM) with an interaction between the independent variable (IMR, FFR, RFR) and the time period (before or after TAVI).

  6 Months

Secondary Outcomes (2)

• Diagnostic accuracy by considering FFR values of >0.80 as normal

  6 Months

• Diagnostic accuracy by considering RFR values of >0.89 as normal

  6 Months

Study Arms (1)

Coronary physiology

OTHER

Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.

Procedure: Assession of complete coronary physiology

Interventions

Assession of complete coronary physiology PROCEDURE

Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.

Also known as: FFR, RFR, CFR, IMR, and CT-FFR

Coronary physiology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
• Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team
• Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out
• CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).
• Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR)
• Eligible for coronary CT-angiography and functional assessment (CT-FFR)

You may not qualify if:

• Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation
• Previous coronary artery bypass grafting with patent grafts to the interrogated vessel
• Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis
• Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
• Contraindication to adenosine (e.g. bronchial asthma)
• Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR \<30 ml/min)
• Presence of cardiogenic shock
• Participation in another interventional study involving the left heart or coronary arteries

Sponsors & Collaborators

• Helios Health Institute GmbH: lead
• Heart Center Leipzig - University Hospital: collaborator

Study Sites (1)

Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology

Leipzig, 04289, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Nicolas Majunke, Dr.

  Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

  STUDY CHAIR

• Robin Gohmann, Dr.

  Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

  PRINCIPAL INVESTIGATOR

• Mohamed Abdel-Wahab, Prof. Dr.

  Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Majunke, Dr.

CONTACT

+49 341 865 1428; nicolas.majunke@medizin.uni-leipzig.de

Mohamed Abdel-Wahab, Prof. Dr.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single center, open-label

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: September 29, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-09

Locations

DE (1)