Portico and Navitor India Clinical Trial

NCT05171712 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10387
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Failure; Aortic Insufficiency; Aortic Stenosis

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (1)

Analysis Population

EXPERIMENTAL

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

Interventions

Transcatheter Aortic Valve Replacement DEVICE

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

Analysis Population

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Apollo Hospital

Chennai, India

Location

Medanta-The Medicity

Gūrgaon, India

Location

Rajasthan Hospital

Jaipur, India

Location

Seth GS Medical College & KEM Hospital

Mumbai, India

Location

Vardhman Mahavir Medical College & Safdarjung Hospital

New Delhi, India

Location

Christian Medical College & Hospital

Vellore, India

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Results Point of Contact

• Title: Karine Miquel
• Organization: Abbott

karine.miquel@abbott.com

+32 479 600 107

Study Officials

• Barathi Sethuraman

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 29, 2021
• Study Start: May 6, 2022
• Primary Completion: December 21, 2024
• Study Completion: January 28, 2025
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)