NCT06510855

Brief Summary

A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
63mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jan 2025Aug 2031

First Submitted

Initial submission to the registry

July 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

July 15, 2024

Last Update Submit

April 28, 2026

Conditions

Severe Aortic Valve StenosisAortic Valve CalcificationAortic Valve FailureAortic Valve DiseaseSymptomatic Aortic Stenosis

Keywords

Transcatheter Aortic Valve Implantation (TAVI)Transcatheter Aortic Valve Replacement (TAVR)Transcatheter ValveValve-in-ValveAortic Valve Disease

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality or disabling stroke

    Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines

    30 Days

Secondary Outcomes (8)

  • All-cause mortality

    30 Days

  • Disabling stroke

    30 Days

  • Life-threatening bleeding

    30 Days

  • Major vascular, access-related, or cardiac structural complication

    30 Days

  • Acute kidney injury stage 3 or 4

    30 Days

  • +3 more secondary outcomes

Study Arms (2)

Severe Aortic Stenosis (sAS) Cohort

EXPERIMENTAL

Subjects with symptomatic severe native aortic stenosis with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Device: DurAVR™ THV System

Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort

EXPERIMENTAL

Subjects with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Device: DurAVR™ THV System

Interventions

DurAVR™ THV SystemDEVICE

DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure

Failed Surgical Aortic Bioprosthetic Valve (FAV) CohortSevere Aortic Stenosis (sAS) Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
  • Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
  • Eligible for transfemoral delivery of the DurAVR™ THV
  • Anatomy appropriate to accommodate safe placement of DurAVR™ THV
  • Understands the study requirements and the treatment procedures and provides written informed consent
  • Subject agrees to complete all required scheduled follow-up visits.

You may not qualify if:

  • Anatomy precluding safe placement of DurAVR™ THV
  • Pre-existing prosthetic mitral or tricuspid valve
  • Unicuspid, bicuspid or non-calcified aortic valve
  • Severe mitral or severe tricuspid regurgitation requiring intervention
  • Moderate to severe mitral stenosis
  • Hypertrophic obstructive cardiomyopathy
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
  • Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  • End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min
  • GI bleeding within the past 3 months
  • Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
  • Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region of Denmark, 2100, Denmark

Location

MeSH Terms

Conditions

Aortic Valve StenosisAortic Valve, Calcification ofAortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 19, 2024

Study Start

January 21, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2031

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)