Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI

NCT04281771 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Radboud University Medical Center

Phase

Not applicable

Started

2019-09-17

Last updated

2024-01-19

Condition(s) studied

Transcatheter Aortic Valve ReplacementHemodynamic MonitoringAortic Valve InsufficiencyAortic Valve StenosisHeyde's SyndromeAcquired Von Willebrand Disease

Investigational drug(s) / intervention(s)

cardiac MRI

cardiac MRI: Patients are studied on a clinical 1.5 Tesla scanner with cardiac radiofrequency receiver coil centered over the heart, and ECG monitoring. The following parameters are assessed: Functional imaging: ECG-gated cine Steady-state free precession (SSFP) MRI images are obtained during repeated breath holds in long axis and short axis orientations covering the entire left ventricle. Global systolic and diastolic function are assessed, and left ventricular mass is calculated. Flow imaging: ECG-gated 2D flow measurements are assessed above the prosthetic valve, and at the level of the pulmonary trunk.

Study summary

Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks. Paravalvular leakage after TAVI is relatively common and there is conflicting evidence regarding the clinical impact of mild paravalvular leakage in self-expanding devices. Prospective data for self-expanding devices are required to compare the extent of paravalvular leakage as a result of device design. Grading paravalvular leakage after TAVI is difficult. Echocardiography and angiography systematically underestimate paravalvular leakage (PVL) as compared to cardiac MRI. Hemodynamic measurements are used to aid decision making directly after TAVI implantation. Prospective data comparing hemodynamic measurements with cardiac MRI are needed to design an optimal strategy to grade paravalvular leakage peri-operatively in order to optimize TAVI outcomes. The combination of aortic valve stenosis, angiodysplasia and von Willebrand Disease type 2A (vWD-2A) is known as Heyde syndrome. Previous studies have shown a decrease in angiodysplastic lesions after TAVI. However, since PVL after TAVI is relatively common, angiodysplastic lesions tend to reoccur. Prospective data comparing the severity of PVL to the severity of both vWD-2A and angiodysplasia are lacking.

Objective: To assess procedural hemodynamic measurements in patients with paravalvular regurgitation quantified by means of cardiac MRI (CMR) and to analyse its association with impaired clinical outcome during 5-year follow-up. Secondary objectives are to assess whether the severity of vWD-2A correlates with the severity of PVL measured by cardiac MRI, and to prospectively assess the success percentage of TAVI in the treatment of angiodysplasia.

Study design: This is a prospective, single-center clinical trial. Patients will receive a TAVI. After implantation different hemodynamic indices of PVL will be assessed. Within 4-8 weeks after TAVI a cardiac MRI will be performed to quantify the amount of PVL. Standardized clinical follow-up will take place at discharge, 30 days, 3 months, 6 months and 1 year. Telephone follow-up will take place at 2, 3, 4 and 5 years after TAVI. In patients with known angiodysplasia or iron deficiency anemia e.c.i., a videocapsule endoscopy (VCE) will take place before TAVI and 6 months after TAVI. Of note, for the substudy on Heyde syndrome, patients with a different type of TAVI valve (i.e. no Abbott Portico valve) are also allowed to participate.

Study population: Approximately 80 patients with severe symptomatic aortic valve stenosis with an indication for TAVI will be included. At least 76 patients with a cardiac MRI that is of sufficient quality to quantify the amount of PVL will be included.

Intervention: Patients will undergo cardiac MRI on top of standard clinical care within 4-8 weeks after TAVI. A subgroup of patients will also undergo a VCE.

Main study parameters/endpoints: The primary endpoint is defined as PVL regurgitation fraction as measured by cardiac MRI. One secondary endpoint will comprise a composite of device success, early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) (1) and will comprise death, vascular complications, stroke/TIA, life-threatening bleeding requiring transfusion, and acute kidney injury requiring dialysis. Another secondary endpoint will be the reduction of angiodysplastic lesions after TAVI as determined by VCE.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The hemodynamic indices can be assessed in a standard fashion using a fluid filled pigtail catheter that is placed in the left ventricle as part of the routine protocol. Following TAVI, enrolled patients will undergo cardiac MRI to assess PVL. The risk of cardiac MRI after TAVI implantation is negligible. Extra blood samples will be taken. After one year, patients will be followed by telephonic follow-up. Risk/benefit: the expected benefit is a structured clinical follow-up at 1, 2, 3, 4 and 5 years, at the cost of an extra visit to undergo cardiac MRI.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients must be \>18 years old. 2. Written informed consent is obtained from all patients. 3. Severe aortic valve stenosis is defined as: jet velocity greater than 4.0m/s or Doppler Velocity index \<0.25 or an initial aortic valve area (AVA) of ≤ 1.0cm² (indexed EOA≤06 cm²/m²) as measured by trans thoracic echocardiography \<6months prior to inclusion. 4. Patients have symptomatic aortic stenosis, as demonstrated by New York Heart Association (NYHA) functional class 2 or greater or other symptoms of aortic stenosis (e.g. syncope or angina in the absence of coronary artery disease). 5. Surgical risk is deemed high or intermediate by Society of Thoracic Surgery (STS) risk score or by documented Heart-team agreement due to frailty or co-morbidities. 6. The aortic annulus diameter as measured by ECG-triggered CT-scanning \< 6months prior to inclusion meets the ranges indicated in the instructions for use. 7. The access artery diameters (femoral or subclavian) as measured by CT-scanning \< 6 months prior to inclusion meet the ranges indicated in the instruction for use. 8. There are no contra-indications (e.g.: severe claustrophobia, metal implants, severe renal failure) for and patient is willing to undergo cardiac MRI at discharge to 30 days after TAVI. Exclusion Criteria: 1. Patient is unwilling or unable to comply with study-required follow-up evaluations. 2. There is evidence of a myocardial infarction within 30 days to index procedure. 3. The presence of severe mitral regurgitation or stenosis. 4. The presence of pre-existing prosthetic cardiac device, valve or prosthetic ring in any position. 5. Left ventricular ejection fraction (LVEF) less than 30%. 6. Untreated significant coronary artery disease requiring revascularization. 7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation suggesting active endocarditis. 8. The patient is hemodynamically unstable, requiring inotropic or vasopressive and / or mechanical support. 9. The presence of pulmonary edema or intra venous diuretics to stabilize heart failure at index procedure. 10. Renal insufficiency, defined as a serum creatinin greater than 250umol/l or end-stage renal disease requiring dialysis. 11. Morbid obesity, defined as a BMI ≥40. 12. A life expectancy of less than one year.

Primary outcome measure(s)

The PVL regurgitation fraction — within 30 days after TAVI
as measured by cardiac MRI

Trial sites (1)

Facility	City	Region	Status
Radboudumc	Nijmegen	Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04281771 on ClinicalTrials.gov ↗ ← All trials in the Netherlands