Transcatheter Aortic Valve Implantation Without Predilation (SIMPLIFy TAVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Bonn
Sponsor:
Information provided by (Responsible Party):
Georg Nickenig, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01539746
First received: February 21, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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%).


Condition Intervention
Aortic Stenosis
Left Ventricular Function Systolic Dysfunction
High-risk Patients
Transcatheter Aortic Valve Implantation
Procedure: TAVI without BAV
Procedure: TAVI standard procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Primary composite efficacy endpoint [ Time Frame: 30 days after TAVI ] [ Designated as safety issue: Yes ]
    Occurrence of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation at 30 days after TAVI.


Secondary Outcome Measures:
  • Cardiovascular & all-cause mortality [ Time Frame: 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Major/minor stroke [ Time Frame: 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • conduction disturbances and pacemaker implantation rate [ Time Frame: 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Rate of postdilation [ Time Frame: 30 days, 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Transvalvular mean gradient as assessed by echocardiography [ Time Frame: 30 days, 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Re-hospitalization for symptoms of cardiac/valve-related decompensation [ Time Frame: 30 days, 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Life-threatening/major/minor bleeding [ Time Frame: 30 days, 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Vascular access complications [ Time Frame: 30 days, 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]
  • Repeat procedure for valve-related dysfunction (surgical or interventional therapy) [ Time Frame: 30 days, 6 months, 12 months after TAVI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539746

Contacts
Contact: Jan-Malte Sinning, MD +49-228-287-15507 jan-malte.sinning@ukb.uni-bonn.de

Locations
Germany
Department of Medicine II - Cardiology, University Hospital Bonn Recruiting
Bonn, Germany, 53105
Contact: Jan-Malte Sinning, MD         
Principal Investigator: Georg Nickenig, MD         
Principal Investigator: Jan-Malte Sinning, MD         
Department of Cardiology, University Hospital Düsseldorf Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Malte Kelm, MD         
Principal Investigator: Malte Kelm, MD         
West German Heart Center, University Hospital Essen Not yet recruiting
Essen, Germany, 45122
Contact: Raimund Erbel, MD         
Principal Investigator: Raimund Erbel, MD         
Principal Investigator: Philipp Kahlert, MD         
Department of Medicine III - Cardiology, University Hospital Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Contact: Hugo A Katus, MD         
Principal Investigator: Hugo A Katus, MD         
Principal Investigator: Raffi Bekeredjian, MD         
Department of Cardiology, Hospital Barmherzige Brüder Trier Not yet recruiting
Trier, Germany, 54292
Contact: Karl Eugen Hauptmann, MD         
Principal Investigator: Karl Eugen Hauptmann, MD         
Department of Medicine III - Cardiology, University Hospital Tübingen Not yet recruiting
Tübingen, Germany, 72076
Contact: Meinrad Gawaz, MD         
Principal Investigator: Meinrad Gawaz, MD         
Sponsors and Collaborators
University Hospital, Bonn
Investigators
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
  More Information

Publications:

Responsible Party: Georg Nickenig, Director, Department of Medicine II, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01539746     History of Changes
Other Study ID Numbers: SIMPLIFy TAVI Trial
Study First Received: February 21, 2012
Last Updated: January 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
Aortic stenosis
Transcatheter aortic valve implantation
TAVI
Predilation
Balloon valvuloplasty
BAV
CoreValve

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 27, 2014