Portico and Navitor India Clinical Trial
- Conditions
- Aortic Valve StenosisAortic Valve FailureAortic StenosisAortic Insufficiency
- Interventions
- Device: Transcatheter Aortic Valve Replacement
- Registration Number
- NCT05171712
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Analysis Population Transcatheter Aortic Valve Replacement 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
- Primary Outcome Measures
Name Time Method VARC-2 and VARC-3 defined event rate of All cause mortality rate (percent of subjects) at 30 days from the implant/index procedure 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, 1-33VARC-2 and VARC-3 defined event rate of Cardiovascular mortality rate (percent of subjects) at 30 days from the implant/index procedure 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 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 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 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 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 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)) 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 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 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 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 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 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 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 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Christian Medical College & Hospital
🇮🇳Vellore, 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