Severe Native Calcific Aortic StenosisVOYAGER CENCT07696182
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
A study testing Prospective, single-arm, multi-center study. in people with Severe Native Calcific Aortic Stenosis and Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis, run by Abbott Medical Devices.
Trial summary
VOYAGER CE Clinical Study using the Encantor TAVI System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
- What is being tested?
- Prospective, single-arm, multi-center study.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Dec 2038
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject identified as appropriate for transcatheter heart valve intervention therapy for the treatment of symptomatic, severe aortic stenosis.
- Subject is of legal age for consent (18 years old).
- Willing to return for required follow-up visits and assessments
Who cannot join
- Pregnant or nursing subjects.
- Need for emergency surgery for any reason
- Anatomic or comorbid conditions
- Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lauren Harvey contact
About this study
Official title: VOYAGER CE Clinical Trial : Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
Read the detailed description
The VOYAGER CE trial is a prospective, single-arm, multi-center, pre-market clinical investigation designed to evaluate the safety and performance of the Encantor TAVI System. This clinical trial will enroll subjects who have symptomatic heart disease due to severe native calcific aortic stenosis and who are judged by a heart team to be appropriate for transcatheter valve replacement therapy.
- Conditions
- Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
- Being tested
- Prospective, single-arm, multi-center study.
- Keywords
- transcatheter valve replacement therapy, symptomatic heart disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective, single-arm, multi-center study.Device
This intervention is distinguished by the use of the Encantor TAVI System, a transcatheter valve replacement therapy specifically designed for patients with symptomatic severe native calcific aortic stenosis who are considered appropriate candidates by a multidisciplinary heart team. This device is intended to provide a minimally invasive alternative to surgical aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter valve replacement therapy | Experimental | Transcatheter valve replacement therapy Receives: Device: Prospective, single-arm, multi-center study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality or all strokes at 12 months post index
Composite of all-cause mortality or all strokes
Measured: 12 months post index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Native Calcific Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashish Oza, Study director, Abbott Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696182
- Sponsor's protocol ID
- ABT-CIP-10647
- Acronym
- VOYAGER CE
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes