NCT02668484

Brief Summary

There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

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 Start

First participant enrolled

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

January 26, 2016

Last Update Submit

May 31, 2019

Conditions

Aortic Valve Disease

Keywords

TAVItrans-femoralSapienLotus

Outcome Measures

Primary Outcomes (1)

  • Incidence of new permanent pacemaker implantation

    implantation of PM

    30 days

Secondary Outcomes (9)

  • incidence of any prosthesis regurgitation

    30 days

  • Incidence of any conduction abnormalities

    30 days

  • Device success rate according to VARC-2 definition

    30 days

  • Mortality rate

    30 days

  • Mortality rate

    1 year

  • +4 more secondary outcomes

Study Arms (2)

repositionable valve prosthesis

EXPERIMENTAL

Lotus

Device: repositionable valve prosthesis

balloon-expandable valve prosthesis

ACTIVE COMPARATOR

Sapien

Device: balloon-expandable valve prosthesis

Interventions

repositionable valve prosthesisDEVICE

repositionable valve prosthesis implanted via trans-femoral and trans-catheter route

Also known as: Lotus
repositionable valve prosthesis
balloon-expandable valve prosthesisDEVICE

balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route

Also known as: Sapien
balloon-expandable valve prosthesis

Eligibility Criteria

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

You may qualify if:

  • Symptomatic aortic valve disease in need of valve replacement
  • Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate.
  • Study patient is an adult of legal consent age.
  • Study patient has provided written informed consent to participate in the study

You may not qualify if:

  • Life expectancy \< 12 months due to co-morbid conditions.
  • Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation
  • Preexisting bioprosthetic valve or ring in aortic valve position.
  • Pre-existing pacemaker or ICD/CRT.
  • Cardiogenic shock or hemodynamic instability.
  • History of active endocarditis
  • Contraindications for a trans-femoral access.
  • Severe left ventricular dysfunction with LVEF \<30%.
  • Severe mitral valve insufficiency.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
  • Patients suffering from dementia.
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Munich University Clinic, Ludwig-Maximilians University

Munich, Bavaria, 81377, Germany

Location

Segeberger Kliniken Gmbh

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Julinda Mehilli, MD

    Munich University Clinic, Ludwig-Maximilians University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Interventional Cardiology

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 31, 2019

Last Updated

June 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)IT(1)