Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcatheter Aortic Valve Implantation Without Predilation (SIMPLIFy TAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01539746
Recruitment Status : Unknown
Verified January 2013 by Georg Nickenig, University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : February 27, 2012
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Georg Nickenig, University Hospital, Bonn

Tracking Information
First Submitted Date  ICMJE February 21, 2012
First Posted Date  ICMJE February 27, 2012
Last Update Posted Date January 31, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2012)
  • Cardiovascular & all-cause mortality [ Time Frame: 30 days, 6 months, 12 months after TAVI ]
  • Major/minor stroke [ Time Frame: 30 days, 6 months, 12 months after TAVI ]
  • Myocardial infarction [ Time Frame: 30 days, 6 months, 12 months after TAVI ]
  • Conduction disturbances and pacemaker rate [ Time Frame: 30 days, 6 months, 12 months after TAVI ]
  • Acute kidney injury [ Time Frame: 30 days, 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcatheter Aortic Valve Implantation Without Predilation
Official Title  ICMJE 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
Brief 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%).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Stenosis
  • Left Ventricular Function Systolic Dysfunction
  • High-risk Patients
  • Transcatheter Aortic Valve Implantation
Intervention  ICMJE
  • Procedure: TAVI without BAV
    Avoidance of balloon valvuloplasty (BAV) of the native aortic valve before valve deployment
  • Procedure: TAVI standard procedure
    TAVI standard procedure including BAV before valve deployment
Study Arms  ICMJE
  • Experimental: TAVI without predilation
    Intervention: Procedure: TAVI without BAV
  • Active Comparator: Standard TAVI procedure
    Intervention: Procedure: TAVI standard procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 24, 2012)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01539746
Other Study ID Numbers  ICMJE SIMPLIFy TAVI Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Georg Nickenig, University Hospital, Bonn
Study Sponsor  ICMJE University Hospital, Bonn
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospital, Bonn
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP