NCT01539746

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%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

January 9, 2013

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

6.9 years

First QC Date

February 21, 2012

Last Update Submit

November 4, 2022

Conditions

Aortic StenosisLeft Ventricular Function Systolic DysfunctionHigh-risk PatientsTranscatheter Aortic Valve Implantation

Keywords

Aortic stenosisTranscatheter aortic valve implantationTAVIPredilationBalloon valvuloplastyBAVCoreValve

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days after TAVI

Secondary Outcomes (12)

  • Cardiovascular & all-cause mortality

    6 months, 12 months after TAVI

  • Major/minor stroke

    6 months, 12 months after TAVI

  • Myocardial infarction

    6 months, 12 months after TAVI

  • conduction disturbances and pacemaker implantation rate

    6 months, 12 months after TAVI

  • Acute kidney injury

    6 months, 12 months after TAVI

  • +7 more secondary outcomes

Study Arms (2)

TAVI without predilation

EXPERIMENTAL
Procedure: TAVI without BAV

Standard TAVI procedure

ACTIVE COMPARATOR
Procedure: TAVI standard procedure

Interventions

TAVI without BAVPROCEDURE

Avoidance of balloon valvuloplasty (BAV) of the native aortic valve before valve deployment

TAVI without predilation
TAVI standard procedurePROCEDURE

TAVI standard procedure including BAV before valve deployment

Standard TAVI procedure

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Medicine II - Cardiology, University Hospital Bonn

Bonn, 53105, Germany

Location

Department of Cardiology, University Hospital Düsseldorf

Düsseldorf, 40225, Germany

Location

West German Heart Center, University Hospital Essen

Essen, 45122, Germany

Location

Department of Medicine III - Cardiology, University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Department of Cardiology, Hospital Barmherzige Brüder Trier

Trier, 54292, Germany

Location

Department of Medicine III - Cardiology, University Hospital Tübingen

Tübingen, 72076, Germany

Location

Related Publications (9)

  • 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.

    PMID: 21777882BACKGROUND

  • Leon 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.

    PMID: 21216553BACKGROUND

  • Leon 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.

    PMID: 20961243BACKGROUND

  • Sinning 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.

    PMID: 22285582BACKGROUND

  • Nuis 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.

    PMID: 21622979BACKGROUND

  • Kahlert 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.

    PMID: 21220739BACKGROUND

  • Ghanem 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.

    PMID: 20188503BACKGROUND

  • Drews 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.

    PMID: 21442580BACKGROUND

  • Sinning 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.

    PMID: 21087750BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Georg Nickenig, MD

    Department of Medicine II, University Hospital Bonn

    PRINCIPAL INVESTIGATOR

  • Jan-Malte Sinning, MD

    Department of Medicine II, University Hospital Bonn

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Medicine II

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

January 9, 2013

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations

DE(6)