To evaluate the performance of Portico & Navitor heart Valve in Indian patients

Prospective, non-randomized, two-phase, multicenter Phase IV clinical trial for patients clinically indicated for implantation of a Portico or Navitor transcatheter aortic heart valve - None

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041689

Enrollment

Registered

2022-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis

Interventions

Intervention1: Transcatheter Aortic Valve Implant: Portico or Navitor valve will be implanted through transcatheter aortic valve implantation in patients who have a high or extreme risk for surgery

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1.Have tested positive for the 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)

Design outcomes

Primary

Measure	Time frame
The objective of this Phase IV clinical trial is to characterize the procedural safety and device performance of the Portico valve, Navitor valve, FlexNav delivery system and loading system, and Navitor loading system to treat patients with severe aortic stenosisTimepoint: 30 days, 9 months	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr Sumit Anand

Abbott India Pvt.Ltd.

sumit.anand@abbott.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026