Assessing Aortic Valve Function After TAVR
Standardized Invasive Hemodynamics for Monitoring Acute and Long Term Valve Performance in Patients With Elevated Gradients Post Transcatheter Aortic Valve Replacement
University of British Columbia · NCT04827238
This study is testing how well different methods measure the performance of a new aortic valve after it's been replaced to help improve care for patients with aortic stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | University of British Columbia (other) |
| Locations | 10 sites (Tucson, Arizona and 9 other locations) |
| Trial ID | NCT04827238 on ClinicalTrials.gov |
What this trial studies
The DISCORDANCE TAVR study aims to evaluate the differences between echocardiography-derived and invasive measurements of aortic valve gradients following transcatheter aortic valve replacement (TAVR). It employs a standardized invasive hemodynamics technique to ensure consistent and reproducible results. The study focuses on understanding the impact of flow states on prosthetic valve performance and the occurrence of pseudo-severe prosthesis-patient mismatch (PPM). By analyzing these factors, the study seeks to improve the assessment of aortic stenosis severity post-TAVR.
Who should consider this trial
Good fit: Ideal candidates include patients with echocardiographic transaortic mean gradients of 20mmHg or greater, or those meeting VARC-3 criteria for moderate hemodynamic valve deterioration post-TAVR.
Not a fit: Patients with CT evidence of leaflet thrombosis or hypoattenuated leaflet thickening will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of aortic valve function, improving patient outcomes after TAVR.
How similar studies have performed: While there have been studies on echocardiography and valve performance, this specific approach using standardized invasive hemodynamics is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 criteria for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE \> 1 month post-TAVR * Consensus by the Heart Team that the patient is suitable for Standardized Invasive Hemodynamics (SIH). Exclusion Criteria: * CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT)
Where this trial is running
Tucson, Arizona and 9 other locations
- PIMA Heart Centre — Tucson, Arizona, United States (RECRUITING)
- Tenet Health — Boca Raton, Florida, United States (RECRUITING)
- eCommunity — Indianapolis, Indiana, United States (RECRUITING)
- Community Hospital — Munster, Indiana, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- William Beaumont Hospital — Southfield, Michigan, United States (RECRUITING)
- Baylor Scott & White — Dallas, Texas, United States (WITHDRAWN)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- McMaster University — Hamilton, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: David Wood, MD — University of British Columbia
- Study coordinator: Denise Spacek
- Email: dspacek@cci-cic.org
- Phone: 6048381081
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Stenosis, Aortic Valve Stenosis