Portico and Navitor India Clinical Trial

Abbott

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Insufficiency; Aortic Valve Failure; Aortic Stenosis

Treatments: Device: Transcatheter Aortic Valve Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT05171712

ABT-CIP-10387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Analysis Population

Experimental group

Description:

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

Treatment:

Device: Transcatheter Aortic Valve Replacement