Balloon Expandable Transcatheter Aortic Valve Implantatio... | NCT02127580

Studies
Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve

NCT02127580

Sponsor

Institut für Pharmakologie und Präventive Medizin

Status

Completed

Last Update Posted

Apr 27, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

BAV
without BAV

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

Mar 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 29, 2014

First Submission Date that Met QC Criteria

Apr 29, 2014

First Posted Date

Apr 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2018

Last Update Posted Date

Apr 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is usually performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation is aiming at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects, such as:

Functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia.
In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS). Both are associated with a high periprocedural mortality.
BAV has been identified as a major source of thrombotic and valvular material and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke.
The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BAV	Procedure		with BAV
without BAV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VARC2 criteria	comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Holger Schröfel, MD	Clinic for Cardiac Surgery Karlsruhe	Principal Investigator
Justus Strauch, Prof.	Klinik für Herz- und Thoraxchirurgie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic for Cardiac Surgery Karlsruhe		Karlsruhe	Baden-Wurttemberg	76185	Germany
Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29182764	Result	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.
25403092

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases