Clinical trial NCT05171712: Portico and Navitor India Clinical Trial
Official title: Portico and Navitor India Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Failure
Aortic Insufficiency
Aortic Stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: VARC-2 and VARC-3 defined event rate of All cause mortality rate (percent of subjects) at 30 days from the implant/index procedure
timeFrame: 30 days post index procedure
measure: VARC-2 and VARC-3 defined event rate of Cardiovascular mortality rate (percent of subjects) at 30 days from the implant/index procedure
timeFrame: 30 days post index procedure
measure: VARC-2 and VARC-3 defined event rate of Myocardial Infarction rate (percent of subjects) at 30 days from the implant/index procedure
timeFrame: 30 days post index procedure
measure: 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
timeFrame: 30 days post index procedure
measure: 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
timeFrame: 30 days post index procedure
measure: VARC-2 and VARC-3 defined event rate of Acute kidney injury (percent of subjects) at 30 days from the implant/index procedure
timeFrame: 30 days post index procedure
measure: 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
timeFrame: 30 days post index procedure
measure: VARC-2 and VARC-3 defined event rate of Coronary obstruction (percent of subjects) at 30 days from the implant/index procedure
timeFrame: 30 days post index procedure
measure: VARC-2 and VARC-3 defined event rate of Permanent pacemaker insertion (percent of subjects) at 30 days from the implant/index procedure
timeFrame: 30 days post index procedure
measure: Access Vessel Diameter (mm) during procedure
timeFrame: During procedure
measure: Sheath Utilization during procedure
timeFrame: During procedure
measure: Sheath Size during procedure
timeFrame: During procedure
measure: Percentage of Subjects with Implant Success
timeFrame: During procedure
measure: Echocardiographic assessment of the mean gradient at 30 days compared to baseline for the subjects with Portico valve implanted
timeFrame: 30 days post index procedure
measure: Echocardiographic assessment of Effective Orifice Area (EOA) at 30 days compared to baseline for the subjects with Portico valve
timeFrame: 30 days post index procedure
measure: Echocardiographic assessment of Paravalvular Leak (PVL) per VARC-2 definitions at 30 days compared to baseline for the subjects with Portico valve implanted
timeFrame: 30 days post index procedure
measure: 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
timeFrame: 9 months post index procedure
measure: 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
timeFrame: 9 months post index procedure
measure: 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
timeFrame: 30 days post index procedure
measure: 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))
timeFrame: 9 months post index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Apollo Hospital
city: Gurgaon
country: India
facility: Medanta-The Medicity
city: Jaipur
country: India
facility: Rajasthan Hospital
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
city: New Delhi
country: India
facility: Vardhman Mahavir Medical College & Safdarjung Hospital
city: Vellore
country: India
facility: Christian Medical College & Hospital
Study officials:
affiliation: Abbott
name: Barathi Sethuraman
role: STUDY_DIRECTOR
References: