NCT02162069

Brief Summary

To evaluate the long-term results after transcatheter aortic valve replacement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
843

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

4.5 years

First QC Date

June 7, 2014

Last Update Submit

April 25, 2020

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Major adverse cerebral and cardiac events.

    1-5 years

Study Arms (1)

transcatheter aortic valve replacement

EXPERIMENTAL

Patients receive transcatheter aortic valve replacement.

Device: CE certified transcatheter ( aortic valve replacement)

Interventions

CE certified transcatheter ( aortic valve replacement)DEVICE

Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.

transcatheter aortic valve replacement

Eligibility Criteria

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

You may qualify if:

  • aortic valve stenosis
  • transcatheter aortic valve replacement

You may not qualify if:

  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm

Ulm, 89081, Germany

Location

Related Publications (7)

  • Seeger J, Gonska B, Otto M, Rottbauer W, Wohrle J. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2297-2303. doi: 10.1016/j.jcin.2017.06.037. Epub 2017 Sep 13.

    PMID: 28917515BACKGROUND

  • Seeger J, Kapadia SR, Kodali S, Linke A, Wohrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis. Eur Heart J. 2019 May 1;40(17):1334-1340. doi: 10.1093/eurheartj/ehy847.

    PMID: 30590554RESULT

  • Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13.

    PMID: 35576863DERIVED

  • Seeger J, Gonska B, Rottbauer W, Wohrle J. New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome. Cardiovasc Interv Ther. 2018 Jul;33(3):247-255. doi: 10.1007/s12928-017-0477-6. Epub 2017 Jun 22.

    PMID: 28643214DERIVED

  • Seeger J, Gonska B, Rottbauer W, Wohrle J. Outcome With the Repositionable and Retrievable Boston Scientific Lotus Valve Compared With the Balloon-Expandable Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve Replacement. Circ Cardiovasc Interv. 2017 Jun;10(6):e004670. doi: 10.1161/CIRCINTERVENTIONS.116.004670.

    PMID: 28566290DERIVED

  • Seeger J, Gonska B, Rodewald C, Rottbauer W, Wohrle J. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol. 2016 Nov 15;223:564-567. doi: 10.1016/j.ijcard.2016.08.193. Epub 2016 Aug 17.

    PMID: 27561160DERIVED

  • Wohrle J, Gonska B, Rodewald C, Seeger J, Scharnbeck D, Rottbauer W. Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. PLoS One. 2016 Mar 22;11(3):e0151247. doi: 10.1371/journal.pone.0151247. eCollection 2016.

    PMID: 27003573DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jochen Wöhrle, MD

    University of Ulm, Ulm, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: TAVR
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jochen Wöhrle

Study Record Dates

First Submitted

June 7, 2014

First Posted

June 12, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

DE(1)