Skip to main content
OpenTrials
Completed

NCT Number: NCT05171712

Portico and Navitor India Clinical Trial

The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Valve Stenosis Aortic Insufficiency Aortic Stenosis Aortic Valve Disease Aortic Valve Failure Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Apollo Hospital, Chennai, India

Loading trial locations.

About this study

The objective of this Phase IV clinical trial is to characterize the procedural safety and device performance of the Portico valve, the Navitor Valve, the FlexNav delivery system and FlexNav or Navitor loading system to treat patients with severe aortic stenosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must provide written informed consent prior to any clinical investigation-related procedure.
  • 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.
  • 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

  • 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.)
  • Have sepsis, including active endocarditis
  • Have any evidence of left ventricular or atrial thrombus
  • Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
  • Have a non-calcified aortic annulus
  • Have congenital bicuspid or unicuspid leaflet configuration
  • Are unable to tolerate antiplatelet/anticoagulant therapy
  • Are pregnant at the time of signing informed consent
  • Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)

Treatment and study plan

Transcatheter Aortic Valve Replacement

Device

Transcatheter Aortic Valve Replacement for the treatment of patients with severe aortic stenosis

Primary outcomes

  1. VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  2. VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  3. Myocardial Infarction Rate

    Time frame: 30 days post index procedure

    Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure

  4. VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  5. VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  6. VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  7. VARC-2 Defined Event Rate of Vascular Access Site and Access-related Complications (Major and Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  8. VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  9. VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure

    Time frame: 30 days post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  10. Percentage of Subjects With Implant Success

    Time frame: During procedure

    Defined as absence of procedural mortality, correct positioning of a single Portico prosthetic heart valve into the proper anatomical location, no conversion to open surgery

  11. Echocardiographic Assessment of the Mean Aortic Gradient

    Time frame: 30 days post index procedure

    Units=mmHg

  12. Echocardiographic Assessment of Effective Orifice Area (EOA)

    Time frame: 30 days post index procedure

    units = cm2

  13. Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.

    Time frame: 30 days post index procedure

    Reported as either none/trace, mild, moderate, or severe

  14. VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure

    Time frame: 9 months post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  15. VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure

    Time frame: 9 months post index procedure

    The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions:

    1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.

  16. New York Heart Association (NYHA) Functional Class

    Time frame: 30 days post index procedure

    Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV.

  17. New York Heart Association (NYHA) Functional Class

    Time frame: 9 months post index procedure

    Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented.

  18. EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire

    Time frame: 30 Days

    Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.

  19. EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire

    Time frame: 9 Months

    Patients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 29, 2021
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.