Navitor TAVI valve in Japanese patients with severe aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm, observational multicenter post-market study will enroll approximately 100 Japanese patients with symptomatic severe aortic stenosis who are planned to receive the Navitor TAVI system. All procedures will use the Navitor valve with the FlexNav delivery system and may include future commercially available device iterations as they become available in Japan. Subjects will be followed at hospital discharge, 30 days, and one year after the index procedure to collect safety and performance outcomes in a real-world setting. Eligibility is determined by the treating Heart Team according to the approved device indication and the study uses routine clinical follow-up without randomized controls.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.
2. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.
3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).
2. Life expectancy \< 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
3. In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
5. Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
6. Currently participating in an investigational drug or device study that may confound the results of this study.
7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.

Where it's running

• Kokura Memorial Hospital
  Fukuoka, Japan Recruiting
• Shonan Kamakura General Hospital
  Kanagawa, Japan Recruiting
• Osaka Keisatsu Hospital
  Osaka, Japan Recruiting

Study contacts

• Study coordinator: Bart Janssens
• Email: bart.janssens@abbott.com
• Phone: +32471723201

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

  Recruiting Yan'an Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07469371

• RENATUS transcatheter aortic valve for severe aortic stenosis

  This trial tests the RENATUS transcatheter aortic valve in people with symptomatic severe aortic stenosis who are eligible for TAVR.

  Recruiting at 4 sites Beijing Balance Medical Technology Co., Ltd · Beijing and 3 other locations · NCT07414342

• Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

  The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.

  Recruiting at 2 sites Atlantic Health System · Detroit, Michigan and 1 other locations · NCT07309029

• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

  This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.

  Recruiting Anteris Technologies Ltd. · Copenhagen, Capital Region of Denmark · NCT07194265

• Improving quality of life for patients with severe aortic stenosis

  This study looks at how severe aortic stenosis affects the daily lives of patients to see if a new heart valve procedure can help improve their quality of life.

  Recruiting Hospices Civils de Lyon · Clermont-Ferrand and 3 other locations · NCT06477042

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.