Portico and Navitor India Clinical Trial

Aortic Valve Stenosis Clinical Trial

Official title:

Portico and Navitor India Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05171712
• Other study ID #: ABT-CIP-10387
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Stenosis
• Aortic Valve Failure
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
India	Apollo Hospital	Chennai
India	Medanta-The Medicity	Gurgaon
India	Rajasthan Hospital	Jaipur
India	Seth GS Medical College & KEM Hospital	Mumbai
India	Vardhman Mahavir Medical College & Safdarjung Hospital	New Delhi
India	Christian Medical College & Hospital	Vellore

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days post index procedure
Primary	VARC-2 and VARC-3 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 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.	30 days post index procedure
Primary	VARC-2 and VARC-3 defined event rate of Myocardial Infarction 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.	30 days post index procedure
Primary	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	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.	30 days post index procedure
Primary	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	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.	30 days post index procedure
Primary	VARC-2 and VARC-3 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 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.	30 days post index procedure
Primary	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	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.	30 days post index procedure
Primary	VARC-2 and VARC-3 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 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.	30 days post index procedure
Primary	VARC-2 and VARC-3 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 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.	30 days post index procedure
Primary	Access Vessel Diameter (mm) during procedure	The access vessel diameter (mm) will be analyzed at index/implant procedure to define delivery profile characteristics	During procedure
Primary	Sheath Utilization during procedure	The Sheath Utilization will be analyzed at index/implant procedure to define delivery profile characteristics (unit = percent using sheath)	During procedure
Primary	Sheath Size during procedure	The Sheath Size will be analyzed at index/implant procedure to define delivery profile characteristics (unit = French (F))	During procedure
Primary	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
Primary	Echocardiographic assessment of the mean gradient at 30 days compared to baseline for the subjects with Portico valve implanted	Units=mmHg	30 days post index procedure
Primary	Echocardiographic assessment of Effective Orifice Area (EOA) at 30 days compared to baseline for the subjects with Portico valve	units = cm2	30 days post index procedure
Primary	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	30 days post index procedure
Primary	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	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.	9 months post index procedure
Primary	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	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.	9 months post index procedure
Primary	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.	30 days post index procedure
Primary	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	9 months post index procedure