NCT05171712

Portico and Navitor India Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Failure
• Aortic Insufficiency
• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Replacement	Transcatheter Aortic Valve Replacement for the treatment of patients with severe aortic stenosis

Timeline

• Start date: 2022-05-06
• Primary completion: 2024-12-21
• Completion: 2025-01-28
• First posted: 2021-12-29
• Last updated: 2026-04-15
• Results posted: 2026-04-15

Locations

6 sites across 1 country: India

Regulatory

• FDA-regulated device study