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Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF) (EASE-IT-TF)

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ClinicalTrials.gov Identifier: NCT02760771
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief 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. 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.


Condition or disease Intervention/treatment
Aortic Stenosis Other: with BAV Other: without BAV

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 196 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
Actual Study Start Date : May 2016
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
with BAV
patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) with predilation of the aortic valve
Other: with BAV
balloon dilation of the aortic valve prior to implantation of the THV

without BAV
patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) without predilation of the aortic valve
Other: without BAV
no balloon dilation of the aortic valve prior to implantation of the THV




Primary Outcome Measures :
  1. Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation [ Time Frame: within 30 days after TAVI ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: within 30 days after TAVI ]
  2. Stroke [ Time Frame: within 30 days after TAVI ]
  3. Non-fatal myocardial infarction [ Time Frame: within 30 days after TAVI ]
  4. pacemaker implantation [ Time Frame: within 30 days after TAVI ]
  5. acute kidney injury [ Time Frame: within 30 days after TAVI ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for transfemoral transcatheter valve implantation with commercially available Edwards Transcatheter Heart Valves.
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Males or females
  • At least 18 years of age

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760771


Locations
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Germany
Medizinische Klinik IV, Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Württemberg, Germany, 76133
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Investigators
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Principal Investigator: Gerhard Schymick, MD Städtisches Klinikum Karlsruhe
Principal Investigator: David Wendt, PD MD Westdeutsches Herzzentrum Essen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT02760771     History of Changes
Other Study ID Numbers: EASE-IT-TF
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Institut für Pharmakologie und Präventive Medizin:
THV (trans-catheter heart valve)
severe aortic stenosis
pre-dilation
rapid pacing
BAV (balloon artery valvuloplasty

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction