Aortic StenosisSIMPLIFy TAVINCT01539746
Transcatheter Aortic Valve Implantation Without Predilation
A study testing TAVI without BAV and TAVI standard procedure in people with Aortic Stenosis and Left Ventricular Function Systolic Dysfunction, run by University Hospital, Bonn at 6 sites in Germany.
Trial summary
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction (LVEF ≤35%). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Stenosis, Left Ventricular Function Systolic Dysfunction, High-risk Patients
- What is being tested?
- TAVI without BAV and TAVI standard procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesGermany
- Study dates
- 9 Jan 2013to 22 Nov 2019
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF ≤35%
- Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
- Males or females at least 18 years of age
- Logistic EuroSCORE ≥15% and age ≥75 years or if age <75 years: logistic EuroSCORE ≥20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD)
- Signed informed consent
Who cannot join
- Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator)
- Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines
- Lack of written informed consent, severe mental disorder, drug/alcohol addiction
- Life expectancy < 1 year
- Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated
- Recent myocardial infarction (STEMI within the last 3 months)
Show all 20Show fewer
- Left ventricular or atrial thrombus by echocardiography
- Uncontrolled atrial fibrillation
- Mitral or tricuspidal valvular insufficiency (> grade II)
- Previous aortic valve replacement with mechanical valve
- Evolutive or recent cerebrovascular event (within the last 3 months)
- Vascular conditions that make insertion and endovascular access to the aortic valve impossible
- Symptomatic carotid or vertebral arterial narrowing (>70%) disease
- Abdominal or thoracic aortic aneurysm in the path of the delivery system
- Bleeding diathesis or coagulopathy or patient refusing blood transfusion
- Active gastritis or peptic ulcer disease
- Severely impaired renal function, GFR < 30 ml/min
- Participation in another drug or device study that would jeopardize the appropriate analysis of end-points of this study.
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Department of Medicine II - Cardiology, University Hospital Bonn
Bonn, 53105
Department of Cardiology, University Hospital Düsseldorf
Düsseldorf, 40225
West German Heart Center, University Hospital Essen
Essen, 45122
Department of Medicine III - Cardiology, University Hospital Heidelberg
Heidelberg, 69120
Department of Cardiology, Hospital Barmherzige Brüder Trier
Trier, 54292
Department of Medicine III - Cardiology, University Hospital Tübingen
Tübingen, 72076
About this study
Official title: Use of the Self-Expanding Medtronic CoreValve Prosthesis Without Predilation in Patients With Severely IMPaired Left-VentrIcular Ejection Fraction for TAVI Trial - The SIMPLIFy TAVI Trial
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction (LVEF ≤35%).
Read the detailed description
Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk. Before deployment of transcatheter heart valves (THV), current medical practice requires right-ventricular rapid burst pacing (>180 bpm) with induction of a functional cardiac arrest for up to 30 seconds for balloon aortic valvuloplasty (BAV). This step is thought to be necessary to predilate the native aortic valve and to facilitate an accurate positioning of the THV. However, BAV has been shown to have numerous detrimental effects: i) the functional cardiac arrest induced by rapid pacing for BAV leads to transient coronary, cerebral, and renal ischemia. ii) In patients with impaired left ventricular ejection fraction, prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS), which are both associated with a high peri-procedural mortality. iii) BAV has been identified as a major source of embolization of thrombotic and valvular material and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke. iv) the local trauma in the left-ventricular outflow tract caused by BAV contributes to conduction disturbances with the need for permanent pacemaker implantation after TAVI.
A non-randomized pilot study by Grube et al. (JACC Interventions 2011) has recently shown that TAVI without BAV is feasible and safe, since self-expanding THV are able to "dilate" the stenosed aortic valve through the radial forces of the self-expanding nitinol frame, in which the prosthesis is mounted. According to the mentioned study, omitting BAV allows the delivery of the THV in a controlled fashion without hemodynamic compromise of the patient.
Patients with LVEF≤35% will be randomized (like the flip of a coin) to TAVI without BAV (experimental group) or TAVI with BAV for predilation (control group).
- Conditions
- Aortic Stenosis, Left Ventricular Function Systolic Dysfunction, High-risk Patients, Transcatheter Aortic Valve Implantation
- Being tested
- TAVI without BAV, TAVI standard procedure
- Keywords
- Aortic stenosis, Transcatheter aortic valve implantation, TAVI, Predilation, Balloon valvuloplasty, BAV, CoreValve
- 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.
TAVI without BAVProcedure or surgery
Avoidance of balloon valvuloplasty (BAV) of the native aortic valve before valve deployment
TAVI standard procedureProcedure or surgery
TAVI standard procedure including BAV before valve deployment
| Study group | Role | What they receive |
|---|---|---|
| TAVI without predilation | Experimental | Not described Receives: Procedure: TAVI without BAV |
| Standard TAVI procedure | Active comparator | Not described Receives: Procedure: TAVI standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary composite efficacy endpoint
Occurrence of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation at 30 days after TAVI.
Measured: 30 days after TAVI
Secondary outcomes (12)
Cardiovascular & all-cause mortality
Measured: 6 months, 12 months after TAVI
Major/minor stroke
Measured: 6 months, 12 months after TAVI
Myocardial infarction
Measured: 6 months, 12 months after TAVI
conduction disturbances and pacemaker implantation rate
Measured: 6 months, 12 months after TAVI
Acute kidney injury
Measured: 6 months, 12 months after TAVI
Rate of postdilation
Measured: 30 days, 6 months, 12 months after TAVI
Transvalvular mean gradient as assessed by echocardiography
Measured: 30 days, 6 months, 12 months after TAVI
Re-hospitalization for symptoms of cardiac/valve-related decompensation
Measured: 30 days, 6 months, 12 months after TAVI
Severity of periprosthetic aortic regurgitation (AR) as assessed by echocardiography, angiography, and hemodynamic measurements (AR index)
Measured: 30 days, 6 months, 12 months after TAVI
Life-threatening/major/minor bleeding
Measured: 30 days, 6 months, 12 months after TAVI
Vascular access complications
Measured: 30 days, 6 months, 12 months after TAVI
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Measured: 30 days, 6 months, 12 months after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study start9 Jan 2013
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Nickenig, University Hospital, Bonn
- Investigators
- Georg Nickenig, MD, Principal investigator, Department of Medicine II, University Hospital BonnJan-Malte Sinning, MD, Study director, Department of Medicine II, University Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539746
- Sponsor's protocol ID
- SIMPLIFy TAVI Trial
- Acronym
- SIMPLIFy TAVI
- Status last verified
- Nov 2022
- First submitted
- 21 Feb 2012
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Grube E, Naber C, Abizaid A, Sousa E, Mendiz O, Lemos P, Kalil Filho R, Mangione J, Buellesfeld L. Feasibility of transcatheter aortic valve implantation without balloon pre-dilation: a pilot study. JACC Cardiovasc Interv. 2011 Jul;4(7):751-7. doi: 10.1016/j.jcin.2011.03.015.
PubMed 21777882Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7.
PubMed 21216553Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Sinning JM, Scheer AC, Adenauer V, Ghanem A, Hammerstingl C, Schueler R, Muller C, Vasa-Nicotera M, Grube E, Nickenig G, Werner N. Systemic inflammatory response syndrome predicts increased mortality in patients after transcatheter aortic valve implantation. Eur Heart J. 2012 Jun;33(12):1459-68. doi: 10.1093/eurheartj/ehs002. Epub 2012 Jan 26.
PubMed 22285582Nuis RJ, Van Mieghem NM, Schultz CJ, Tzikas A, Van der Boon RM, Maugenest AM, Cheng J, Piazza N, van Domburg RT, Serruys PW, de Jaegere PP. Timing and potential mechanisms of new conduction abnormalities during the implantation of the Medtronic CoreValve System in patients with aortic stenosis. Eur Heart J. 2011 Aug;32(16):2067-74. doi: 10.1093/eurheartj/ehr110. Epub 2011 May 28.
PubMed 21622979Kahlert P, Erbel R. Transcatheter aortic valve implantation in the era after commercialization: quo vadis in the real world? Circulation. 2011 Jan 25;123(3):239-41. doi: 10.1161/CIRCULATIONAHA.110.004713. Epub 2011 Jan 10. No abstract available.
PubMed 21220739Ghanem A, Muller A, Nahle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010 Apr 6;55(14):1427-32. doi: 10.1016/j.jacc.2009.12.026. Epub 2010 Feb 24.
PubMed 20188503Drews T, Pasic M, Buz S, Unbehaun A, Dreysse S, Kukucka M, Mladenow A, Hetzer R. Transcranial Doppler sound detection of cerebral microembolism during transapical aortic valve implantation. Thorac Cardiovasc Surg. 2011 Jun;59(4):237-42. doi: 10.1055/s-0030-1250495. Epub 2011 Mar 25.
PubMed 21442580Sinning JM, Ghanem A, Steinhauser H, Adenauer V, Hammerstingl C, Nickenig G, Werner N. Renal function as predictor of mortality in patients after percutaneous transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2010 Nov;3(11):1141-9. doi: 10.1016/j.jcin.2010.09.009.
PubMed 21087750
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Self-Expanding Medtronic CoreValve Prosthesis Without Predilation in Patients With Severely IMPaired Left-VentrIcular Ejection Fraction for TAVI Trial - The SIMPLIFy TAVI Trial
- ClinicalTrials.gov ID
- NCT01539746
- Acronym / sponsor ID
- SIMPLIFy TAVI / SIMPLIFy TAVI Trial
- Conditions
- Aortic Stenosis, Left Ventricular Function Systolic Dysfunction, High-risk Patients, Transcatheter Aortic Valve Implantation
- Keywords
- Aortic stenosis, Transcatheter aortic valve implantation, TAVI, Predilation, Balloon valvuloplasty, BAV, CoreValve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 9 Jan 2013 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 27 Feb 2012 (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.
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction (LVEF ≤35%).
Detailed description
Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk. Before deployment of transcatheter heart valves (THV), current medical practice requires right-ventricular rapid burst pacing (>180 bpm) with induction of a functional cardiac arrest for up to 30 seconds for balloon aortic valvuloplasty (BAV). This step is thought to be necessary to predilate the native aortic valve and to facilitate an accurate positioning of the THV. However, BAV has been shown to have numerous detrimental effects: i) the functional cardiac arrest induced by rapid pacing for BAV leads to transient coronary, cerebral, and renal ischemia. ii) In patients with impaired left ventricular ejection fraction, prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS), which are both associated with a high peri-procedural mortality. iii) BAV has been identified as a major source of embolization of thrombotic and valvular material and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke. iv) the local trauma in the left-ventricular outflow tract caused by BAV contributes to conduction disturbances with the need for permanent pacemaker implantation after TAVI.
A non-randomized pilot study by Grube et al. (JACC Interventions 2011) has recently shown that TAVI without BAV is feasible and safe, since self-expanding THV are able to "dilate" the stenosed aortic valve through the radial forces of the self-expanding nitinol frame, in which the prosthesis is mounted. According to the mentioned study, omitting BAV allows the delivery of the THV in a controlled fashion without hemodynamic compromise of the patient.
Patients with LVEF≤35% will be randomized (like the flip of a coin) to TAVI without BAV (experimental group) or TAVI with BAV for predilation (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI without predilation | Experimental | Procedure: TAVI without BAV |
| Standard TAVI procedure | Active comparator | Procedure: TAVI standard procedure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LVEF ≤35%
- Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
- Males or females at least 18 years of age
- Logistic EuroSCORE ≥15% and age ≥75 years or if age <75 years: logistic EuroSCORE ≥20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD)
- Signed informed consent
Key exclusion criteria (20 listed)
- Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator)
- Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines
- Lack of written informed consent, severe mental disorder, drug/alcohol addiction
- Life expectancy < 1 year
- Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated
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 |
|---|---|---|
| TAVI without BAVAvoidance of balloon valvuloplasty (BAV) of the native aortic valve before valve deployment | Procedure or surgery | TAVI without predilation |
| TAVI standard procedureTAVI standard procedure including BAV before valve deployment | Procedure or surgery | Standard TAVI procedure |
Primary outcome
Primary composite efficacy endpoint
Time frame: 30 days after TAVI
Occurrence of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation at 30 days after TAVI.
12 secondary outcomes
Cardiovascular & all-cause mortality
Time frame: 6 months, 12 months after TAVI
Major/minor stroke
Time frame: 6 months, 12 months after TAVI
Myocardial infarction
Time frame: 6 months, 12 months after TAVI
conduction disturbances and pacemaker implantation rate
Time frame: 6 months, 12 months after TAVI
Acute kidney injury
Time frame: 6 months, 12 months after TAVI
Rate of postdilation
Time frame: 30 days, 6 months, 12 months after TAVI
Transvalvular mean gradient as assessed by echocardiography
Time frame: 30 days, 6 months, 12 months after TAVI
Re-hospitalization for symptoms of cardiac/valve-related decompensation
Time frame: 30 days, 6 months, 12 months after TAVI
Severity of periprosthetic aortic regurgitation (AR) as assessed by echocardiography, angiography, and hemodynamic measurements (AR index)
Time frame: 30 days, 6 months, 12 months after TAVI
Life-threatening/major/minor bleeding
Time frame: 30 days, 6 months, 12 months after TAVI
Vascular access complications
Time frame: 30 days, 6 months, 12 months after TAVI
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Time frame: 30 days, 6 months, 12 months after TAVI
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 7 Nov 2022.
- Background: PubMed 21777882Grube E, Naber C, Abizaid A, Sousa E, Mendiz O, Lemos P, Kalil Filho R, Mangione J, Buellesfeld L. Feasibility of transcatheter aortic valve implantation without balloon pre-dilation: a pilot study. JACC Cardiovasc Interv. 2011 Jul;4(7):751-7. doi: 10.1016/j.jcin.2011.03.015.
- Background: PubMed 21216553Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18;57(3):253-69. doi: 10.1016/j.jacc.2010.12.005. Epub 2011 Jan 7.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 22285582Sinning JM, Scheer AC, Adenauer V, Ghanem A, Hammerstingl C, Schueler R, Muller C, Vasa-Nicotera M, Grube E, Nickenig G, Werner N. Systemic inflammatory response syndrome predicts increased mortality in patients after transcatheter aortic valve implantation. Eur Heart J. 2012 Jun;33(12):1459-68. doi: 10.1093/eurheartj/ehs002. Epub 2012 Jan 26.
- Background: PubMed 21622979Nuis RJ, Van Mieghem NM, Schultz CJ, Tzikas A, Van der Boon RM, Maugenest AM, Cheng J, Piazza N, van Domburg RT, Serruys PW, de Jaegere PP. Timing and potential mechanisms of new conduction abnormalities during the implantation of the Medtronic CoreValve System in patients with aortic stenosis. Eur Heart J. 2011 Aug;32(16):2067-74. doi: 10.1093/eurheartj/ehr110. Epub 2011 May 28.
- Background: PubMed 21220739Kahlert P, Erbel R. Transcatheter aortic valve implantation in the era after commercialization: quo vadis in the real world? Circulation. 2011 Jan 25;123(3):239-41. doi: 10.1161/CIRCULATIONAHA.110.004713. Epub 2011 Jan 10. No abstract available.
- Background: PubMed 20188503Ghanem A, Muller A, Nahle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010 Apr 6;55(14):1427-32. doi: 10.1016/j.jacc.2009.12.026. Epub 2010 Feb 24.
- Background: PubMed 21442580Drews T, Pasic M, Buz S, Unbehaun A, Dreysse S, Kukucka M, Mladenow A, Hetzer R. Transcranial Doppler sound detection of cerebral microembolism during transapical aortic valve implantation. Thorac Cardiovasc Surg. 2011 Jun;59(4):237-42. doi: 10.1055/s-0030-1250495. Epub 2011 Mar 25.
- Background: PubMed 21087750Sinning JM, Ghanem A, Steinhauser H, Adenauer V, Hammerstingl C, Nickenig G, Werner N. Renal function as predictor of mortality in patients after percutaneous transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2010 Nov;3(11):1141-9. doi: 10.1016/j.jcin.2010.09.009.
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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.
Georg Nickenig, MD principal investigator
Department of Medicine II, University Hospital Bonn
Jan-Malte Sinning, MD study director
Department of Medicine II, University Hospital Bonn
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI without BAV and TAVI standard procedure in people with Aortic Stenosis and Left Ventricular Function Systolic Dysfunction, run by University Hospital, Bonn at 6 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 5 inclusion and 20 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Primary composite efficacy endpoint (time frame: 30 days after TAVI). 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 NCT01539746, which also lists 9 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 7 Nov 2022.