NCT04031274: AMTRAC

Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry

Status unknown Last updated 24 July 2019

What this trial tests

trial testing TAVI in Aortic Stenosis in 10,000 participants. Status unknown.

Timeline

1 September 2019

Primary endpoint
1 September 2020

31 December 2020

Quick facts

Lead sponsor	Rabin Medical Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	10,000
Start date	1 September 2019
Primary completion	1 September 2020
Estimated completion	31 December 2020
Sites	1 location across Israel

Drugs / interventions tested

• TAVI
• TMVR/r

Conditions studied

• Aortic Stenosis — all drugs for Aortic Stenosis →
• Mitral Regurgitation — all drugs for Mitral Regurgitation →

Sponsor

Rabin Medical Center

Who can join

Eligibility, any sex, with Aortic Stenosis or Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

an international multicentre registry designed to answer 3 clinical questions:

1. Describing the characteristics and outcomes of current patients undergoing aortic + mitral transcatheter heart valve procedures.
2. Better understanding of the predictors for MR regression following isolated TAVI and consequently estimating the fraction of patients who will be suitable for TMVR/r post TAVI
3. Examining the clinical outcomes of patients with significant MR post TAVI who subsequently underwent TMVR/r compared to those left for medical management.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality.
   Witberg G, Codner P, Landes U, Schwartzenberg S, et al · · 2021 · cited 56× · PMID 33992550 · DOI 10.1016/j.jcin.2021.02.030
2. Transcatheter Treatment of Residual Significant Mitral Regurgitation Following TAVR: A Multicenter Registry.
   Witberg G, Codner P, Landes U, Barbanti M, et al · · 2020 · cited 40× · PMID 33303117 · DOI 10.1016/j.jcin.2020.07.014
3. Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry.
   Witberg G, Landes U, Talmor-Barkan Y, Richter I, et al · · 2022 · cited 12× · PMID 35738747 · DOI 10.1016/j.jcin.2022.05.004
4. Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.
   Witberg G, Levi A, Talmor-Barkan Y, Barbanti M, et al · · 2024 · cited 10× · PMID 38629416 · DOI 10.4244/eij-d-23-00948
5. Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.
   Witberg G, Landes U, Codner P, Barbanti M, et al · · 2022 · cited 4× · PMID 34673502 · DOI 10.4244/eij-d-21-00613
6. Non-Invasive Assessment of Multivalvular Heart Disease: A Comprehensive Review.
   De Zan G, van der Bilt IAC, Broekhuizen LN, Cramer MJ, et al · · 2024 · cited 3× · PMID 39077670 · DOI 10.31083/j.rcm2501029
7. Aortic Valve Calcium Score Spectrum Identifies Bimodal Outcomes for Transcatheter Aortic Valve Implantation: Insights From the AMTRAC Registry.
   Talmor-Barkan Y, Barbanti M, Valvo R, Costa G, et al · · 2026 · PMID 41804901 · DOI 10.1161/jaha.125.045425