Everyday Practice With Transcatheter Aortic Valve Implantation

NCT ID: NCT02289339

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2018-05-20

Brief Summary

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The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.

Detailed Description

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The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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TAVI patients

all patients undergoing transcatheter aortic valve prostheses implantation

aortic valve prostheses

Intervention Type DEVICE

balloon-expandable and self-expandable aortic valve prostheses

Interventions

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aortic valve prostheses

balloon-expandable and self-expandable aortic valve prostheses

Intervention Type DEVICE

Other Intervention Names

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CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotus

Eligibility Criteria

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Inclusion Criteria

* Aortic stenosis
* Intermediate-to-high risk for surgery
* Heart team decision

Exclusion Criteria

* Contraindication to transfemoral TAVI procedure
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Julinda Mehilli

Prof. MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julinda Mehilli, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Department, Munich University Clinic, Ludwig-Maximilian University

Steffen Massberg, Prof. MD

Role: STUDY_CHAIR

Cardiology Department, Munich University Clinic, Ludwig-Maximilian University

Locations

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Cardiology Department, Segeberger Kliniken

Bad Segeberg, , Germany

Site Status

Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University

Munich, , Germany

Site Status

Countries

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Germany

References

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Jochheim D, Zadrozny M, Ricard I, Sadry TM, Theiss H, Baquet M, Schwarz F, Bauer A, Khandoga A, Sadoni S, Pichlmaier M, Hausleiter J, Hagl C, Massberg S, Mehilli J. Predictors of cerebrovascular events at mid-term after transcatheter aortic valve implantation - Results from EVERY-TAVI registry. Int J Cardiol. 2017 Oct 1;244:106-111. doi: 10.1016/j.ijcard.2017.03.003.

Reference Type RESULT
PMID: 28784441 (View on PubMed)

Mehilli J, Jochheim D, Abdel-Wahab M, Rizas KD, Theiss H, Spenkuch N, Zadrozny M, Baquet M, El-Mawardy M, Sato T, Lange P, Kuppatt C, Greif M, Hausleiter J, Bauer A, Schwarz F, Pichlmaier M, Hagl C, Richardt G, Massberg S. One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation. EuroIntervention. 2016 Nov 20;12(10):1298-1304. doi: 10.4244/EIJV12I10A213.

Reference Type RESULT
PMID: 27866140 (View on PubMed)

Hein-Rothweiler R, Jochheim D, Rizas K, Egger A, Theiss H, Bauer A, Massberg S, Mehilli J. Aortic annulus to left coronary distance as a predictor for persistent left bundle branch block after TAVI. Catheter Cardiovasc Interv. 2017 Mar 1;89(4):E162-E168. doi: 10.1002/ccd.26503. Epub 2016 Apr 1.

Reference Type RESULT
PMID: 27038099 (View on PubMed)

Jochheim D, Zadrozny M, Theiss H, Baquet M, Maimer-Rodrigues F, Bauer A, Lange P, Greif M, Kupatt C, Hausleiter J, Hagl C, Massberg S, Mehilli J. Aortic regurgitation with second versus third-generation balloon-expandable prostheses in patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2015 Jun;11(2):214-20. doi: 10.4244/EIJV11I2A40.

Reference Type RESULT
PMID: 26093840 (View on PubMed)

Jochheim D, Abdel-Wahab M, Mehilli J, Ellert J, Wubken-Kleinfeld N, El-Mawardy M, Pache J, Massberg S, Kastrati A, Richardt G. Significant aortic regurgitation after transfemoral aortic valve implantation: patients' gender as independent risk factor. Minerva Cardioangiol. 2015 Oct;63(5):371-9. Epub 2015 Mar 27.

Reference Type RESULT
PMID: 25812583 (View on PubMed)

Jochheim D, Schneider VS, Schwarz F, Kupatt C, Lange P, Reiser M, Massberg S, Gutierrez-Chico JL, Mehilli J, Becker HC. Contrast-induced acute kidney injury after computed tomography prior to transcatheter aortic valve implantation. Clin Radiol. 2014 Oct;69(10):1034-8. doi: 10.1016/j.crad.2014.05.106. Epub 2014 Jul 10.

Reference Type RESULT
PMID: 25017451 (View on PubMed)

Other Identifiers

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MucS001-14

Identifier Type: -

Identifier Source: org_study_id

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