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New heart valves show promise for severe stenosis in indian patients

NCT ID NCT05171712

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two new heart valves (Portico and Navitor) in 30 Indian patients with severe aortic stenosis, a condition where the heart's main valve narrows. The goal was to see if the valves are safe and work well. Researchers tracked complications and heart function for up to 9 months after the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

May 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation-related procedure. 2. Are \>60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant. 3. Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score. Exclusion Criteria: 1. Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.) 2. Have sepsis, including active endocarditis 3. Have any evidence of left ventricular or atrial thrombus 4. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable 5. Have a non-calcified aortic annulus 6. Have congenital bicuspid or unicuspid leaflet configuration 7. Are unable to tolerate antiplatelet/anticoagulant therapy 8. Are pregnant at the time of signing informed consent 9. Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic insufficiency Aortic stenosis Aortic valve failure Aortic valve stenosis

Contacts and locations

Locations

  • Apollo Hospital

    Chennai, India

  • Christian Medical College & Hospital

    Vellore, India

  • Medanta-The Medicity

    Gurgaon, India

  • Rajasthan Hospital

    Jaipur, India

  • Seth GS Medical College & KEM Hospital

    Mumbai, India

  • Vardhman Mahavir Medical College & Safdarjung Hospital

    New Delhi, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.