CompletedNot Applicable

Portico and Navitor India Clinical Trial

India30 participantsStarted 2022-05-06

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

VARC-2 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

VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure

Timeframe: 30 days post index procedure

Myocardial Infarction Rate

Timeframe: 30 days post 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

Timeframe: 30 days post index procedure

VARC-2 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

VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure

Timeframe: 30 days post index procedure

Trial details

NCT IDNCT05171712

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-21

Results submitted2026-01-13

View on ClinicalTrials.gov More Aortic Valve Stenosis trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

VARC-2 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

VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure

Timeframe: 30 days post index procedure

Myocardial Infarction Rate

Timeframe: 30 days post 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

Timeframe: 30 days post index procedure

VARC-2 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

VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure

Timeframe: 30 days post index procedure