Aortic StenosisEASE-IT-TFNCT02760771
Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
An observational study of Aortic Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 1 site in Germany.
Trial summary
Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- with BAV and without BAV
- How many people
- 196 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Dec 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for transfemoral transcatheter valve implantation with commercially available Edwards Transcatheter Heart Valves.
Who may be able to join
- Signed informed consent
- Males or females
- At least 18 years of age
Who cannot join
- Logistic EuroSCORE I >40%
- Mitral or tricuspid valvular insufficiency (> grade II)
- Previous aortic valve replacement
- Uncontrolled atrial fibrillation
- Left ventricular or atrial thrombus by echocardiography
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Patients with mobile structures on the leaflets
- Need for a cerebral protection device
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik IV, Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Wurttemberg, 76133
About this study
Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often 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 aims 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.
There is limited experience for the balloon expandable Edwards THV on the need for predilation (BAV). Experience so far has only been documented from smaller, uncontrolled case series.
The investigators aim to document the incidence of several kinds of complications in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.
Read the detailed description
Aortic valve predilation aims 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, thus increasing the risk for coronary obstruction with subsequent myocardial infarction and/or stroke.
- The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.
The investigators aim to document the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.
- Conditions
- Aortic Stenosis
- Being tested
- with BAV, without BAV
- Keywords
- THV (trans-catheter heart valve), severe aortic stenosis, pre-dilation, rapid pacing, BAV (balloon artery valvuloplasty
- Medical subject headings
- Aortic Valve Stenosis, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with BAVOther
balloon dilation of the aortic valve prior to implantation of the THV
without BAVOther
no balloon dilation of the aortic valve prior to implantation of the THV
| Study group | Role | What they receive |
|---|---|---|
| with BAV | patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) with predilation of the aortic valve Receives: Other: with BAV | |
| without BAV | patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) without predilation of the aortic valve Receives: Other: without BAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation
Measured: within 30 days after TAVI
Secondary outcomes (5)
All-cause mortality
Measured: within 30 days after TAVI
Stroke
Measured: within 30 days after TAVI
Non-fatal myocardial infarction
Measured: within 30 days after TAVI
pacemaker implantation
Measured: within 30 days after TAVI
acute kidney injury
Measured: within 30 days after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completion8 Jun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gerhard Schymick, MD, Principal investigator, Städtisches Klinikum KarlsruheDavid Wendt, PD MD, Principal investigator, Westdeutsches Herzzentrum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760771
- Sponsor's protocol ID
- EASE-IT-TF
- Acronym
- EASE-IT-TF
- Status last verified
- Feb 2018
- First submitted
- 2 May 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schymik G, Rudolph T, Jacobshagen C, Rothe J, Treede H, Kerber S, Frank D, Sykorova L, Okamoto M, Thoenes M, Deutsch C, Bramlage P, Butter C. Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry. Open Heart. 2019 Oct 3;6(2):e001082. doi: 10.1136/openhrt-2019-001082. eCollection 2019.
PubMed 31673387Butter C, Bramlage P, Rudolph T, Jacobshagen C, Rothe J, Treede H, Kerber S, Frank D, Seilerova L, Schymik G. Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF). BMC Cardiovasc Disord. 2016 Nov 15;16(1):223. doi: 10.1186/s12872-016-0390-4.
PubMed 27846807