Transcatheter Aortic Valve Implantation Without Predilation (SIMPLIFy TAVI)
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| ClinicalTrials.gov Identifier: NCT01539746 |
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Recruitment Status :
Completed
First Posted : February 27, 2012
Last Update Posted : November 7, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aortic Stenosis Left Ventricular Function Systolic Dysfunction High-risk Patients Transcatheter Aortic Valve Implantation | Procedure: TAVI without BAV Procedure: TAVI standard procedure | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 9, 2013 |
| Actual Primary Completion Date : | November 22, 2019 |
| Actual Study Completion Date : | November 22, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: TAVI without predilation |
Procedure: TAVI without BAV
Avoidance of balloon valvuloplasty (BAV) of the native aortic valve before valve deployment |
| Active Comparator: Standard TAVI procedure |
Procedure: TAVI standard procedure
TAVI standard procedure including BAV before valve deployment |
- 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.
- 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 ]
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
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): NCT01539746
| Germany | |
| Department of Medicine II - Cardiology, University Hospital Bonn | |
| Bonn, Germany, 53105 | |
| Department of Cardiology, University Hospital Düsseldorf | |
| Düsseldorf, Germany, 40225 | |
| West German Heart Center, University Hospital Essen | |
| Essen, Germany, 45122 | |
| Department of Medicine III - Cardiology, University Hospital Heidelberg | |
| Heidelberg, Germany, 69120 | |
| Department of Cardiology, Hospital Barmherzige Brüder Trier | |
| Trier, Germany, 54292 | |
| Department of Medicine III - Cardiology, University Hospital Tübingen | |
| Tübingen, Germany, 72076 | |
| Principal Investigator: | Georg Nickenig, MD | Department of Medicine II, University Hospital Bonn | |
| Study Director: | Jan-Malte Sinning, MD | Department of Medicine II, University Hospital Bonn |
| Responsible Party: | Georg Nickenig, Director, Department of Medicine II, University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT01539746 |
| Other Study ID Numbers: |
SIMPLIFy TAVI Trial |
| First Posted: | February 27, 2012 Key Record Dates |
| Last Update Posted: | November 7, 2022 |
| Last Verified: | November 2022 |
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Aortic stenosis Transcatheter aortic valve implantation TAVI Predilation |
Balloon valvuloplasty BAV CoreValve |
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Aortic Valve Stenosis Aortic Valve Disease Heart Valve Diseases |
Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |