Portico and Navitor India Clinical Trial

Abbott Medical Devices30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis Aortic Valve Failure Aortic Insufficiency Aortic Stenosis

Interventions

Transcatheter Aortic Valve ReplacementDEVICE

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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)

Locations (6)

Apollo Hospital

Chennai, India

Medanta-The Medicity

Gūrgaon, India

Rajasthan Hospital

Jaipur, India

Seth GS Medical College & KEM Hospital

Mumbai, India

Outcomes

Primary Outcomes

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: 1. Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23. 2. Genereux et al. European Heart Journal: 2021; 00, 1-33

Time frame: 30 days post index procedure

VARC-2 and VARC-3 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

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

Time frame: 30 days post 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

Time frame: 30 days post 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

Data from ClinicalTrials.gov

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Vardhman Mahavir Medical College & Safdarjung Hospital

Christian Medical College & Hospital

Vellore, India

Time frame: 30 days post 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

Time frame: 30 days post 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

Time frame: 30 days post index procedure

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

Time frame: 30 days post 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

Time frame: 30 days post 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

Time frame: During procedure

Sheath Utilization during procedure

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

Time frame: During procedure

Sheath Size during procedure

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

Time frame: During 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

Time frame: During procedure

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

Units=mmHg

Time frame: 30 days post index procedure

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

units = cm2

Time frame: 30 days post index procedure

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

Time frame: 30 days post index procedure

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

Time frame: 9 months post 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

Time frame: 9 months post 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.

Time frame: 30 days post index procedure

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

Time frame: 9 months post index procedure