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Enrolling by invitationNCT06753227IVEGA-TAVIUpdated Dec 31, 2024

Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart Valves.

An observational study in AORTIC VALVE DISEASES and Aortic Stenosis, sponsored by Deutsches Herzzentrum Muenchen. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Deutsches Herzzentrum Muenchen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this prospective registry is to compare invasive versus echocardiography-derived transvalvular gradients before and after TAVI with balloon-expandable THVs.All patients will undergo a transthoracic echocardiogram in the operating room prior to aortic valve implantation. In addition, two catheters (one in the ventricle and one in the aorta) will be used to invasively measure the transvalvular gradient both before and after aortic valve implantation. The invasive measurements will be performed in different positions of the ventricle and aorta simultaneously. At the end of the procedure, aortic gradient measurement by echocardiography shall be performed again. A maximal three months follow-up is expected.

02

Conditions studied

  • AORTIC VALVE DISEASES
  • Aortic Stenosis

Keywords

  • invasive gradients
  • haemodynamics
  • aortic valve stenosis
  • echocardiographic gradients
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All consecutive patients with severe aortic valve stenosis undergoing TAVI with balloon-expandable transcatheter heart valves (THV).

Inclusion criteria

  • Age ≥ 18 years and able to give consent
  • Severe symptomatic native aortic valve stenosis with indication for TAVI according to 2021 ESC/EACTS Valvular Heart Disease Guidelines.
  • Use of balloon-expandable THV
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Emergency or urgent treatment indication
  • Patients under hemodynamically unstable conditions.
  • Previous bioprosthetic aortic valve implantation
  • Patient cannot adhere to or complete the trial protocol for any reason
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Patients with severe aortic valve stenosis requiring transcatheter aortic valve implantation
05

What researchers measure

Primary outcomes

  1. To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient after TAVI.

    Time frame: From enrollment to 3 months

Secondary outcomes

  1. To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient before TAVI.

    Time frame: From enrollment to 3 months

  2. To compare pulse-wave Doppler above the aortic valve before and after TAVI

    Time frame: From enrollment to 3 months

  3. To compare pre-ejection period time pre and post TAVI.

    Time frame: From enrollment to 3 months

06

Study locations

1 site
  • Deutsches Herzzentrum München
    Munich, Bayern 80636, Germany
07

References and documents

Publications

  • Reddy YNV, Miranda WR, Nishimura RA. Measuring Pressure Gradients After Transcatheter Aortic Valve Implantation: Rethinking the Bernoulli Principle. J Am Heart Assoc. 2021 Oct 5;10(19):e022515. doi: 10.1161/JAHA.121.022515. Epub 2021 Sep 29. No abstract available. PubMed 34585620 ↗
  • Lancellotti P, Pibarot P, Chambers J, Edvardsen T, Delgado V, Dulgheru R, Pepi M, Cosyns B, Dweck MR, Garbi M, Magne J, Nieman K, Rosenhek R, Bernard A, Lowenstein J, Vieira ML, Rabischoffsky A, Vyhmeister RH, Zhou X, Zhang Y, Zamorano JL, Habib G. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Jun;17(6):589-90. doi: 10.1093/ehjci/jew025. Epub 2016 May 3. PubMed 27143783 ↗
  • Herrmann HC, Laskey WK. Pressure loss recovery in aortic valve stenosis: Contemporary relevance. Catheter Cardiovasc Interv. 2022 Jan 1;99(1):195-197. doi: 10.1002/ccd.29729. Epub 2021 Apr 22. PubMed 33886155 ↗
  • Abbas AE, Mando R, Kadri A, Khalili H, Hanzel G, Shannon F, Al-Azizi K, Waggoner T, Kassas S, Pilgrim T, Okuno T, Camacho A, Selberg A, Elmariah S, Bavry A, Ternacle J, Christensen J, Gheewala N, Pibarot P, Mack M. Comparison of Transvalvular Aortic Mean Gradients Obtained by Intraprocedural Echocardiography and Invasive Measurement in Balloon and Self-Expanding Transcatheter Valves. J Am Heart Assoc. 2021 Oct 5;10(19):e021014. doi: 10.1161/JAHA.120.021014. Epub 2021 Sep 29. PubMed 34585593 ↗
  • Abbas AE, Mando R, Hanzel G, Gallagher M, Safian R, Hanson I, Almany S, Pibarot P, Dalal P, Vivacqua A, Sakwa M, Shannon F. Invasive Versus Echocardiographic Evaluation of Transvalvular Gradients Immediately Post-Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2019 Jul;12(7):e007973. doi: 10.1161/CIRCINTERVENTIONS.119.007973. Epub 2019 Jul 5. No abstract available. PubMed 31272227 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT06753227
Lead sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Edwards Lifesciences
Responsible party
Sponsor
First posted
Dec 31, 2024
Start date
May 28, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Dec 31, 2024

Study contacts

Michael Joner, Professor Dr. med.
study director · Deutsches Herzzentrum München

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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