Diagnosed with AR and surgery isn’t an option?*
You may be eligible for a clinical trial involving transcatheter aortic valve replacement (TAVR).
Do you have AR patients who are not eligible for surgery?
Find out more about an investigational TAVR treatment option
Diagnosed with AR and surgery isn’t an option?*
You may be eligible for a clinical trial involving transcatheter aortic valve replacement (TAVR).
The ALIGN-AR clinical trial will study transcatheter aortic valve replacement (TAVR) in patients with symptomatic, severe aortic regurgitation (AR) that are at high risk for surgery. In this trial, the JenaValve Trilogy® TAVR System will be used.
Inclusion Criteria
1. Adult subjects with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric approach with:
- Jet width ≥ 65% of LVOT
- Vena contracta width of > 6 mm
- Holodiastolic flow reversal in proximal abdominal aorta
- Jet deceleration rate/pressure half time < 200ms
AND
For Grade 3
- Regurgitant volume ≥ 45 – 59 ml/beat
- Regurgitant fraction ≥ 40 – 49%
- ERO ≥ 0.2 – 0.29 cm²
OR
For Grade 4
- Regurgitant volume ≥ 60 ml/beat
- Regurgitant fraction ≥ 50%
- ERO ≥ 0.3 cm²
2. Patient symptomatic according to NYHA functional class II or higher
3. Patient with high risk for SAVR as documented by heart team and heart team agrees that patient can undergo SAVR for “bail out”/to address unfavorable circumstances if necessary
4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy® Heart Valve System
5. Patient or the patient’s legal representative has provided written informed consent
6. Patient or the patient’s legal representative agrees to comply with all required post-procedure follow-up visits
Video Resources
Watch to Learn More About AR and the Align AR Trial
TVT Panel Discussion: High-Risk Severe AR Treated with TAVR
Learn about the undertreatment of aortic regurgitation and the possibility of TAVR as an option for high-risk, severe AR patients as Dr. Michael Mack leads an important discussion with Drs. Vinod Thourani, Torsten Vahl, and Nadira Hamid.
TVT Session Presentation: High-Risk Severe AR with TAVR
Review the etiology and prevalence of severe AR, as well as the clinical need for TAVR as a treatment option.
TAVR Procedural Animation: Treating Severe AR with the Trilogy System
The Other Aortic Valve Disease: Aortic Regurgitation – Addressing an Unmet Need for Patients
Dr. Vinod Thourani leads an important discussion with Drs. Mark Russo and James McCabe on aortic regurgitation, treatment options, and the ALIGN AR trial.
*For patients that are at high risk for surgical aortic valve replacement.
Diagnosed with AR and surgery isn’t an option?*
You may be eligible for a clinical trial involving transcatheter aortic valve replacement (TAVR).