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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Aortic Valve Stenosis; Aortic Insufficiency; Aortic Valve Failure
• Intervention / Treatment: Device: Transcatheter Aortic Valve Replacement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chennai, India
    • Apollo Hospital
  • Gūrgaon, India
    • Medanta-The Medicity
  • Jaipur, India
    • Rajasthan Hospital
  • Mumbai, India
    • Seth GS Medical College & KEM Hospital
  • New Delhi, India
    • Vardhman Mahavir Medical College & Safdarjung Hospital
  • Vellore, India
    • Christian Medical College & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Analysis Population; The analysis population will include patients considered at high or extreme surgical risk, who have met all inclusion criteria, have not met any exclusion criteria, have signed an Ethics Committee (EC) approved Informed Consent, and, at the minimum, the FlexNav delivery system entered his/her vasculature for an attempted Portico or Navitor Valve implant	Device: Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Replacement for the treatment of patients with severe aortic stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/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.	30 days post index procedure
VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/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.	30 days post index procedure
Myocardial Infarction Rate	Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure	30 days post index procedure
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/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.	30 days post index procedure
VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/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.	30 days post index procedure
VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/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.	30 days post index procedure
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	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.	30 days post index procedure
VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/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.	30 days post index procedure
VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/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.	30 days post index procedure
Percentage of Subjects With Implant Success	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	During procedure
Echocardiographic Assessment of the Mean Aortic Gradient	Units=mmHg	30 days post index procedure
Echocardiographic Assessment of Effective Orifice Area (EOA)	units = cm2	30 days post index procedure
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.	Reported as either none/trace, mild, moderate, or severe	30 days post index procedure
VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/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.	9 months post index procedure
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/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 months post index procedure
New York Heart Association (NYHA) Functional Class	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.	30 days post index procedure
New York Heart Association (NYHA) Functional Class	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.	9 months post index procedure
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire	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.	30 Days
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire	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.	9 Months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Barathi Sethuraman, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Actual): December 21, 2024
• Study Completion (Actual): January 28, 2025

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: ABT-CIP-10387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes