NCT03497611

Brief Summary

There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets. Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden). Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

March 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

April 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2019

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

March 26, 2018

Last Update Submit

September 2, 2020

Conditions

Aortic Valve StenosisAV BlockBundle-Branch Block

Keywords

Transcatheter aortic valve implantationPacemakerAortic valve calcificationPPI

Outcome Measures

Primary Outcomes (1)

  • occurence of PPI after TAVI

    need for permanent pacemaker implantation after TAVI

    30 days

Secondary Outcomes (2)

  • Timing of PPI

    30 days

  • Indications for PPI

    30 days

Study Arms (1)

Patients with aortic stenosis

Patients receiving Edwards SAPIEN 3 Transcatheter aortic valve implantation

Procedure: transcatheter valve implantation

Interventions

transcatheter valve implantationPROCEDURE

aortic transcatheter valve implantation using Edwards SAPIEN 3 valve

Patients with aortic stenosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that already underwent transfemoral transcatheter valve implantation with the SAPIEN 3 valve

You may qualify if:

  • Patients that already underwent Edwards SAPIEN 3 implantation because of aortic stenosis

You may not qualify if:

  • Patients with prior pacemaker or intended valve in valve implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Clinic Tübingen, Department of Internal Medicine III

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

University Clinic Ulm, Department of Internal Medicine II

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Herzzentrum, Universität Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Münster, Klinik und Poliklinik für Erwachsene mit angeborenen und erworbenen Herzfehlern

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (2)

  • Droppa M, Rudolph TK, Baan J, Nielsen NE, Baumgartner H, Vendrik J, Froehlich M, Borst O, Wohrle J, Gawaz M, Potratz P, Hack LP, Mauri V, Baranowski J, Bramlage P, Kurucova J, Thoenes M, Rottbauer W, Geisler T. Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis. Heart Vessels. 2020 Dec;35(12):1735-1745. doi: 10.1007/s00380-020-01653-6. Epub 2020 Jun 26.

    PMID: 32591894RESULT

  • Rudolph T, Droppa M, Baan J, Nielsen NE, Baranowski J, Hachaturyan V, Kurucova J, Hack L, Bramlage P, Geisler T. Modifiable risk factors for permanent pacemaker after transcatheter aortic valve implantation: CONDUCT registry. Open Heart. 2023 Feb;10(1):e002191. doi: 10.1136/openhrt-2022-002191.

    PMID: 36750275DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisAtrioventricular BlockBundle-Branch BlockAortic Valve, Calcification of

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionHeart BlockArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tobias Geisler, Prof.

    University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 13, 2018

Study Start

April 30, 2018

Primary Completion

November 3, 2018

Study Completion

March 3, 2019

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

no IPD will be made available

Locations

DE(4)