Aortic Valve StenosisEASE-ITNCT02127580
Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 7 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- BAV and without BAV
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 7 sitesGermany
- Study dates
- Apr 2014to May 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 suffering from aortic Stenosis undergoing transapical trans-catheter heart valve implantation
Who may be able to join
- Patients with an indication for TAVI as to the Edwards THV IFU
- Eligible for TABI with AND without BAV
- Signed informed consent
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Klinikum Augsburg
Augsburg, 86156
Herz- und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, 97615
Schüchtermann-Schiller'sche Kliniken
Bad Rothenfelde, 49214
Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil
Bochum, North Rhine-Westphalia, 44789
Uniklinik Köln
Cologne, D-50937
Uniklinik Essen
Essen, 45147
Clinic for Cardiac Surgery Karlsruhe
Karlsruhe, Baden-Wurttemberg, 76185
About this study
Official title: Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry
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).
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- BAV, without BAV
- Keywords
- THV, BAV, pre-dilation, Aortic valve stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAVProcedure or surgery
without BAVProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| with BAV | Patients undergoing TA-TAVI WITH predilation of the AV (Group A) Receives: Procedure: BAV | |
| without BAV | Patients undergoing TA-TAVI WITHOUT predilation of the AV Receives: Procedure: without BAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
VARC2 criteria
comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMay 2016
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 Valve 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 only
- Time perspective
- Prospective
- Enrolment
- 200 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
- Holger Schröfel, MD, Principal investigator, Clinic for Cardiac Surgery KarlsruheJustus Strauch, Prof., Principal investigator, Klinik für Herz- und Thoraxchirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127580
- Sponsor's protocol ID
- EASE-IT
- Acronym
- EASE-IT
- Status last verified
- Apr 2018
- First submitted
- 29 Apr 2014
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29182764Bramlage 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.
PubMed 25403092
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry
- ClinicalTrials.gov ID
- NCT02127580
- Acronym / sponsor ID
- EASE-IT / EASE-IT
- Conditions
- Aortic Valve Stenosis
- Keywords
- THV, BAV, pre-dilation, Aortic valve stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- Apr 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with BAV | – | Procedure: BAVPatients undergoing TA-TAVI WITH predilation of the AV (Group A) |
| without BAV | – | Procedure: without BAVPatients undergoing TA-TAVI WITHOUT predilation of the AV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from aortic Stenosis undergoing transapical trans-catheter heart valve implantation
Key inclusion criteria (3 listed)
- Patients with an indication for TAVI as to the Edwards THV IFU
- Eligible for TABI with AND without BAV
- Signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAV | Procedure or surgery | with BAV |
| without BAV | Procedure or surgery | without BAV |
Primary outcome
VARC2 criteria
Time frame: 3 months
comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Results publication: PubMed 29182764Strauch 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.
- Derived from this study: PubMed 25403092Bramlage 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Schröfel, MD principal investigator
Clinic for Cardiac Surgery Karlsruhe
Justus Strauch, Prof. principal investigator
Klinik für Herz- und Thoraxchirurgie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VARC2 criteria (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127580, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.