Portico and Navitor India Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 30
- Locations
- 7
- Primary Endpoint
- VARC-2 and VARC-3 defined event rate of All cause mortality rate (percent of subjects) at 30 days from the implant/index procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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
Intervention: Transcatheter Aortic Valve Replacement (Device)
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
Time Frame: 30 days post 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
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
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.
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
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.
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
Time Frame: 30 days post 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.
Sheath Size during procedure
Time Frame: During procedure
The Sheath Size will be analyzed at index/implant procedure to define delivery profile characteristics (unit = French (F))
Echocardiographic assessment of the mean gradient at 30 days compared to baseline for the subjects with Portico valve implanted
Time Frame: 30 days post index procedure
Units=mmHg
Echocardiographic assessment of Effective Orifice Area (EOA) at 30 days compared to baseline for the subjects with Portico valve
Time Frame: 30 days post index procedure
units = cm2
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))
Time Frame: 9 months post index procedure
Reported as the percent of subjects with improvement, worsening, or stable from baseline to 30 days and from baseline to 9 months
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
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.
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
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.
Access Vessel Diameter (mm) during procedure
Time Frame: During procedure
The access vessel diameter (mm) will be analyzed at index/implant procedure to define delivery profile characteristics
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
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.
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
Time Frame: 30 days post index procedure
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.
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
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.
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
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.
Sheath Utilization during procedure
Time Frame: During procedure
The Sheath Utilization will be analyzed at index/implant procedure to define delivery profile characteristics (unit = percent using sheath)
Percentage of Subjects with Implant Success
Time Frame: During procedure
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 Paravalvular Leak (PVL) per VARC-2 definitions at 30 days compared to baseline for the subjects with Portico valve implanted
Time Frame: 30 days post index procedure
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
Time Frame: 9 months post 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.
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
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.
VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time Frame: 30 days post 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.
VARC-2 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
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.
Myocardial Infarction Rate
Time Frame: 30 days post index procedure
Myocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/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
Time Frame: 30 days post 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.
VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time Frame: 30 days post 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.
VARC-2 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
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.
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
Time Frame: 30 days post 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.
VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure
Time Frame: 30 days post 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.
VARC-2 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
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.
Percentage of Subjects With Implant Success
Time Frame: During procedure
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 Aortic Gradient
Time Frame: 30 days post index procedure
Units=mmHg
Echocardiographic Assessment of Effective Orifice Area (EOA)
Time Frame: 30 days post index procedure
units = cm2
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.
Time Frame: 30 days post index procedure
Reported as either none/trace, mild, moderate, or severe
VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure
Time Frame: 9 months post 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.
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure
Time Frame: 9 months post 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.
New York Heart Association (NYHA) Functional Class
Time Frame: 30 days post index procedure
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.
New York Heart Association (NYHA) Functional Class
Time Frame: 9 months post index procedure
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.
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
Time Frame: 30 Days
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.
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
Time Frame: 9 Months
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.
Secondary Outcomes
No secondary outcomes reported