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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.

Primary conditionAortic Valve StenosisRegistry: Aortic Valve DiseaseReclassifiedWhy we changed it
Registry
Aortic Valve Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Aortic Valve Stenosis
Why
  1. The study's listed conditions name Aortic Valve Stenosis, a narrower term within Aortic Valve Disease.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Deutsches Herzzentrum Muenchen · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as enrolling by invitation.
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.

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Conditions studied

  • AORTIC VALVE DISEASES
  • Aortic Stenosis

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Keywords

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

In context

Aortic Valve Stenosis Reclassified

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 250 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Deutsches Herzzentrum Muenchen is the lead sponsor of 114 studies on the registry; 10 are open to participants now.

Browse Deutsches Herzzentrum Muenchen studies →

Compared within Aortic Valve Stenosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Valve Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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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
06

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

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Study locations

1 site
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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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2025, 19 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 19 months is below that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2024
First posted
Dec 31, 2024
StartActual
May 28, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
May 31, 2026
Last update
Dec 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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