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Portico and Navitor India Clinical Trial

Primary Purpose

Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency

Status

Recruiting

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Transcatheter Aortic Valve Replacement

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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)

Sites / Locations

Apollo HospitalRecruiting
Rajasthan HospitalRecruiting
Seth GS Medical College & KEM HospitalRecruiting
Vardhman Mahavir Medical College & Safdarjung HospitalRecruiting
Christian Medical College & HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Analysis Population

Arm Description

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

Outcomes

Primary Outcome Measures

VARC-2 and VARC-3 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 and VARC-3 defined endpoints per the published VARC-2 and VARC-3 definitions: Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. Genereux et al. European Heart Journal: 2021; 00, 1-33

VARC-2 and VARC-3 defined event rate of Cardiovascular mortality rate (percent of subjects) at 30 days from the implant/index procedure

VARC-2 and VARC-3 defined event rate of Myocardial Infarction rate (percent of subjects) at 30 days from the implant/index procedure

VARC-2 and VARC-3 defined event rate of Stroke (including disabling and non-disabling, percent of subjects) at 30 days from the implant/index procedure

VARC-2 and VARC-3 defined event rate of Bleeding (life-threatening, major, minor, percent of subjects) at 30 days from the implant/index procedure

VARC-2 and VARC-3 defined event rate of Acute kidney injury (percent of subjects) at 30 days from the implant/index procedure

VARC-2 and VARC-3 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

VARC-2 and VARC-3 defined event rate of Coronary obstruction (percent of subjects) at 30 days from the implant/index procedure

VARC-2 and VARC-3 defined event rate of Permanent pacemaker insertion (percent of subjects) at 30 days from the implant/index procedure

Access Vessel Diameter (mm) during procedure

The access vessel diameter (mm) will be analyzed at index/implant procedure to define delivery profile characteristics

Sheath Utilization during procedure

The Sheath Utilization will be analyzed at index/implant procedure to define delivery profile characteristics (unit = percent using sheath)

Sheath Size during procedure

The Sheath Size will be analyzed at index/implant procedure to define delivery profile characteristics (unit = French (F))

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

Echocardiographic assessment of the mean gradient at 30 days compared to baseline for the subjects with Portico valve implanted

Units=mmHg

Echocardiographic assessment of Effective Orifice Area (EOA) at 30 days compared to baseline for the subjects with Portico valve

units = cm2

Echocardiographic assessment of Paravalvular Leak (PVL) per VARC-2 definitions at 30 days compared to baseline for the subjects with Portico valve implanted

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

VARC-2 and VARC-3 defined event rate of All-Cause Mortality (percent of subjects) beyond 30 days through 9 from the implant/index procedure

VARC-2 and VARC-3 defined event rate of Stroke (including disabling and non-disabling, percent of subjects) beyond 30 days through 9 from the implant/index procedure

Clinical improvement from baseline to 30 days and baseline to 9-months for the subjects with Portico valve implanted assessed by New York Heart Association (NYHA) functional class

Reported as the percent of subjects with improvement, worsening, or stable NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class will be measured as class I, II, III, or IV, symptoms are worsening from I to IV.

Clinical improvement from baseline to 30 days and baseline to 9-months for the subjects with Portico valve implanted assessed by Quality of Life (QoL) questionnaire (5-level EQ-5D version (EQ5D-5L))

Reported as the percent of subjects with improvement, worsening, or stable from baseline to 30 days and from baseline to 9 months

Secondary Outcome Measures

Full Information

NCT ID

NCT05171712

First Posted

October 28, 2021

Last Updated

August 14, 2023

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT05171712

Brief Title

Portico and Navitor India Clinical Trial

Official Title

Portico and Navitor India Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 6, 2022 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Analysis Population

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcatheter Aortic Valve Replacement

Intervention Description

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

Primary Outcome Measure Information:

Title

VARC-2 and VARC-3 defined event rate of All cause mortality rate (percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of Cardiovascular mortality rate (percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of Myocardial Infarction rate (percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of Stroke (including disabling and non-disabling, percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of Bleeding (life-threatening, major, minor, percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of Acute kidney injury (percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 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

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of Coronary obstruction (percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of Permanent pacemaker insertion (percent of subjects) at 30 days from the implant/index procedure

Description

Time Frame

30 days post index procedure

Title

Access Vessel Diameter (mm) during procedure

Description

The access vessel diameter (mm) will be analyzed at index/implant procedure to define delivery profile characteristics

Time Frame

During procedure

Title

Sheath Utilization during procedure

Description

The Sheath Utilization will be analyzed at index/implant procedure to define delivery profile characteristics (unit = percent using sheath)

Time Frame

During procedure

Title

Sheath Size during procedure

Description

The Sheath Size will be analyzed at index/implant procedure to define delivery profile characteristics (unit = French (F))

Time Frame

During procedure

Title

Percentage of Subjects with Implant Success

Description

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

Time Frame

During procedure

Title

Echocardiographic assessment of the mean gradient at 30 days compared to baseline for the subjects with Portico valve implanted

Description

Units=mmHg

Time Frame

30 days post index procedure

Title

Echocardiographic assessment of Effective Orifice Area (EOA) at 30 days compared to baseline for the subjects with Portico valve

Description

units = cm2

Time Frame

30 days post index procedure

Title

Echocardiographic assessment of Paravalvular Leak (PVL) per VARC-2 definitions at 30 days compared to baseline for the subjects with Portico valve implanted

Description

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

Time Frame

30 days post index procedure

Title

VARC-2 and VARC-3 defined event rate of All-Cause Mortality (percent of subjects) beyond 30 days through 9 from the implant/index procedure

Description

Time Frame

9 months post index procedure

Title

VARC-2 and VARC-3 defined event rate of Stroke (including disabling and non-disabling, percent of subjects) beyond 30 days through 9 from the implant/index procedure

Description

Time Frame

9 months post index procedure

Title

Clinical improvement from baseline to 30 days and baseline to 9-months for the subjects with Portico valve implanted assessed by New York Heart Association (NYHA) functional class

Description

Time Frame

30 days post index procedure

Title

Clinical improvement from baseline to 30 days and baseline to 9-months for the subjects with Portico valve implanted assessed by Quality of Life (QoL) questionnaire (5-level EQ-5D version (EQ5D-5L))

Description

Reported as the percent of subjects with improvement, worsening, or stable from baseline to 30 days and from baseline to 9 months

Time Frame

9 months post index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karine Miquel, PhD

Phone

+32479600107

karine.miquel@abbott.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nels Engblom

Phone

(319) 853-3946

nels.engblom1@abbott.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vinny Podichetty

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Apollo Hospital

City

Chennai

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

G Sengottuvelu, Dr

Facility Name

Rajasthan Hospital

City

Jaipur

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ravinder Rao, MD

Facility Name

Seth GS Medical College & KEM Hospital

City

Mumbai

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ajay Mahajan, MD

Facility Name

Vardhman Mahavir Medical College & Safdarjung Hospital

City

New Delhi

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandeep Bansal, Professor

Facility Name

Christian Medical College & Hospital

City

Vellore

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Jose, Professor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Portico and Navitor India Clinical Trial

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