NCT02127580

Brief Summary

There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results of a small case series published by Wendler et. al. to examine hard endpoints such as the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a multicenter registry. We aim to compare the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

7 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

April 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

April 29, 2014

Last Update Submit

April 26, 2018

Conditions

Aortic Valve Stenosis

Keywords

THVBAVpre-dilationAortic valve stenosis

Outcome Measures

Primary Outcomes (1)

  • VARC2 criteria

    comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

    3 months

Study Arms (2)

with BAV

Patients undergoing TA-TAVI WITH predilation of the AV (Group A)

Procedure: BAV

without BAV

Patients undergoing TA-TAVI WITHOUT predilation of the AV

Procedure: without BAV

Interventions

BAVPROCEDURE
with BAV
without BAVPROCEDURE
without BAV

Eligibility Criteria

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

Patients suffering from aortic Stenosis undergoing transapical trans-catheter heart valve implantation

You may qualify if:

  • Patients with an indication for TAVI as to the Edwards THV IFU
  • Eligible for TABI with AND without BAV
  • Signed informed consent

You may not qualify if:

  • Logistic EuroSCORE I \>50%
  • Mitral or tricuspid valvular insufficiency (\> grade II)
  • Previous aortic valve replacement
  • Uncontrolled atrial fibrillation
  • Left ventricular or atrial thrombus by echocardiography
  • Recent cerebrovascular event (within the last 3 months)
  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinic for Cardiac Surgery Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76185, Germany

Location

Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil

Bochum, North Rhine-Westphalia, 44789, Germany

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Herz- und Gefäß-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, 97615, Germany

Location

Schüchtermann-Schiller'sche Kliniken

Bad Rothenfelde, 49214, Germany

Location

Uniklinik Köln

Cologne, D-50937, Germany

Location

Uniklinik Essen

Essen, 45147, Germany

Location

Related Publications (2)

  • Strauch J, Wendt D, Diegeler A, Heimeshoff M, Hofmann S, Holzhey D, Oertel F, Wahlers T, Kurucova J, Thoenes M, Deutsch C, Bramlage P, Schrofel H. Balloon-expandable transapical transcatheter aortic valve implantation with or without predilation of the aortic valve: results of a multicentre registry. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):771-777. doi: 10.1093/ejcts/ezx397.

    PMID: 29182764RESULT

  • Bramlage P, Strauch J, Schrofel H. Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT). BMC Cardiovasc Disord. 2014 Nov 18;14:160. doi: 10.1186/1471-2261-14-160.

    PMID: 25403092DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Holger Schröfel, MD

    Clinic for Cardiac Surgery Karlsruhe

    PRINCIPAL INVESTIGATOR

  • Justus Strauch, Prof.

    Klinik für Herz- und Thoraxchirurgie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

April 30, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

April 27, 2018

Record last verified: 2018-04

Locations

DE(7)