NCT05015452

Brief Summary

A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress57%
Mar 2020Dec 2030

Study Start

First participant enrolled

March 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 9, 2024

Status Verified

September 1, 2024

Enrollment Period

10.8 years

First QC Date

August 16, 2021

Last Update Submit

October 7, 2024

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Cardiovascular and not cardiovascular death 1. identify the current incidence of periprocedural complications. 2. identification of risk groups 3. description of the long-term outcome with special attention to the durability of the different prostheses

    Up to 10 years

Secondary Outcomes (1)

  • Structural valve deterioration

    Up to 10 years

Interventions

Transcatheter Aortic Valve ImplantationDEVICE

Interventional replacement of the aortic valve

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All comers patient population treated with TAVI

You may qualify if:

  • All patients treated with TAVI

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Leipzig

Leipzig, Germany

RECRUITING

Related Publications (1)

  • Abdel-Wahab M, Kitamura M, Fitzgerald SJ, Dumpies O, Wilde J, Gohmann RF, Majunke N, Gutberlet M, Kiefer P, Noack T, Lurz P, Desch S, Frawley C, Ward K, Borger MA, Holzhey D, Thiele H. Neo-Commissural Alignment Technique for Transcatheter Aortic Valve Replacement Using the ACURATE Neo Valve. Circ Cardiovasc Interv. 2022 Jul;15(7):e011993. doi: 10.1161/CIRCINTERVENTIONS.122.011993. Epub 2022 Jul 1. No abstract available.

    PMID: 35775417DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Central Study Contacts

Mohamed Abdel-Wahab, MD

CONTACT

+49 341 865 1428mohamed.bdel-wahab@medizin.uni-leipzig.de

Holger Thiele, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 20, 2021

Study Start

March 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

October 9, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)