Clinical trial NCT06381271: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
Official title: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Regurgitation
Keywords: Aortic Valve Regurgitation
TAVR
Real-Word
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pure severe native aortic valve regurgitation underwent TAVR

Brief summary: The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected

Detailed description: Pure native aortic valve regurgitation (NAVR) is a multifactorial valvular disease, with a prevalence of moderate or severe NAVR ranging from 0.5% to 2.7%. Patients with severe NAVR have a poor prognosis, conservative management has a 1-year mortality rate of more than 20%. Currently, surgical aortic valve replacement (SAVR) is the recommended treatment strategy for patients with NAVR. However, data showed that only 20% of patients with severe NAVR and left-ventricular ejection fraction (LVEF) of 30-50% undergo SAVR, while only 3% of those with an LVEF below 30% receive SAVR. Therefore, a less invasive surgical alternative therapy is needed for high surgical-risk patients from SAVR.

Transcatheter aortic valve replacement (TAVR) is now considered the first-choice treatment for elderly patients with aortic stenosis, regardless of surgical risk. Recently, it has also been used to treat patients with NAVR in an "off-label" setting. The latest European guidelines suggest that TAVR may be considered in experienced centers for selected patients with AR who are not eligible for SAVR. However, the role of TAVR in patients with severe NAVR is still debatable. Current studies on this topic are limited by their retrospective design and small sample sizes.

Dedicated devices for aortic regurgitation, such as the JenaValve, have shown promising results in terms of technical success and short-term outcomes. However, TAVR for patients with NAVR using on-label devices has a relatively high rate of pacemaker implantation. Additionally, the dedicated device was designed only for tricuspid valve anatomy, making TAVR with off-label devices the main invasive strategy for high-surgical risk patients with bicuspid valves. It's worth noting that the dedicated device is not yet commercially available worldwide. Therefore, further investigation into TAVR using off-label devices for NAVR patients, including those with bicuspid and tricuspid valves, is necessary.

The objective of this study was to evaluate the safety and efficacy of TAVR in patients with NAVR in a real-world setting.

Eligibility criteria: Inclusion Criteria:

* 1. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
* 2. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form

Exclusion Criteria:

* 1. Patients who cannot provide informed consent
* 2. Patients who are treated with TAVR for aortic stenosis
* 3. Patients who are participating in other clinical trials

Primary outcomes:
measure: Combined clinical efficacy outcomes
timeFrame: 1 year
Secondary outcomes:
measure: Combined early safety and clinical efficacy outcomes
timeFrame: 30 days
measure: Rate of technical success
timeFrame: at exit from procedure room
measure: Rate of device success
timeFrame: discharge or 30 days
measure: Combined clinical efficacy outcomes
timeFrame: 2 years, 3 years, 4 years
measure: Rate of all-cause mortality
timeFrame: 5years and 10years
measure: Valve-related long-term clinical efficacy
timeFrame: 5 years and 10 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D, Ph.D
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Rutao Wang, M.D, Ph.D
role: STUDY_CHAIR
References: