NCT02448927

Brief Summary

This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV) on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) procedure. Patients will undergo a physical exam, coronary angiography and computed tomography angiography before TAVI. The randomization for direct or non-direct TAVI ( with BAV or without BAV) will take place 24 hours prior to the procedure by the core lab at Hippokration Hospital in Athens. The same lab will analyze in blind fashion the results of all the imaging modalities for each patient. The patients will be followed during the hospital stay and at 30 days and 1 year thereafter by echocardiography. The procedure of predilatation will be at the operator's discretion.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Typical duration for phase_3

Geographic Reach
2 countries

4 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

January 14, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

January 14, 2015

Last Update Submit

September 4, 2019

Conditions

Aortic Valve Stenosis

Keywords

transcatheter aortic valve implantationBalloon aortic valvuloplastyAortic stenosisTAVITAVR (transcatheter aortic valve replacement)CoreValveBAVEvolut R

Outcome Measures

Primary Outcomes (1)

  • Device success

    Device success, as designated by the VARC-2 criteria.

    30 days

Secondary Outcomes (5)

  • Death

    30 days

  • Cerebrovascular accident

    30 days and 1 year

  • New pacemaker implantation

    30 days

  • Vascular complications

    30 days

  • Mortality

    after 30 days and at 1 year

Study Arms (2)

TAVI patients without balloon aortic valvuloplasty

OTHER

Patients that will not undergo balloon aortic valvuloplasty (BAV) before transcatheter aortic valve intervention (TAVI) with the Medtronic Evolut R (or CoreValve).

Device: Transcatheter Aortic Valve Implantation

TAVI patients with balloon aortic valvuloplasty

ACTIVE COMPARATOR

Patients that will undergo balloon aortic valvuloplasty (BAV) before transcatheter aortic valve intervention (TAVI) with the Medtronic Evolut R (or CoreValve).

Device: balloon aortic valvuloplastyDevice: Transcatheter Aortic Valve Implantation

Interventions

balloon aortic valvuloplastyDEVICE
Also known as: BAV
TAVI patients with balloon aortic valvuloplasty
Transcatheter Aortic Valve ImplantationDEVICE
Also known as: TAVI
TAVI patients with balloon aortic valvuloplastyTAVI patients without balloon aortic valvuloplasty

Eligibility Criteria

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

You may qualify if:

  • Diameter of \>5mm for Evolut R and \>6mm for CoreValve of the vessel.
  • Aortic valve diameter of ≥20mm and ≤29mm as measured by echo.
  • Ascending aorta diameter ≤ 43mm at the sinotubular junction.
  • Severe aortic stenosis, defined as aortic valve area of \< 1.0 cm2 (or aortic valve area index of \< 0.6 cm2/m2) by the continuity equation, AND mean gradient \> 40 mmHg or maximal aortic valve velocity \> 4.0 m/sec by resting echocardiogram.
  • STS score of ≥ 8 OR LogEuroSCORE\> 20%, OR
  • years old OR
  • years old with 1 or 2 (but not more than two) from the following criteria:
  • Liver cirrhosis (Class A or B).
  • Pulmonary insufficiency: VMS\<1 liter.
  • Previous heart surgery (CABG, vascular surgery).
  • Porcelain aorta.
  • Pulmonary artery systolic pressure \>60 mmHg and high risk for heart surgery.
  • Relapsing pulmonary embolism.
  • Right ventricular insufficiency.
  • Thoracic wall injuries that contraindicate an open heart surgery.
  • +4 more criteria

You may not qualify if:

  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin and bivalirudin, ticlopidine and clopidogrel, nitinol (titanium or nickel), contrast media
  • Ongoing sepsis, including active endocarditis.
  • Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to Heart Team assessment.
  • Echocardiographic evidence of LV or LA thrombus.
  • Mitral or tricuspid valve insufficiency (\> grade II).
  • Previous aortic valve replacement (mechanical or bioprosthetic).
  • Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • Patients with:
  • Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a transcatheter sheath.
  • OR Symptomatic carotid or vertebral artery disease (\> 70% stenosis).
  • The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.
  • Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
  • Creatinine clearance \< 20 ml/min.
  • Active gastritis or ulcer.
  • Pregnancy.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

First Department of Cardiology, University of Athens

Athens, Attica, 11527, Greece

Location

Department of Cardiology, Onassis Cardiac Surgery Center

Athens, Greece

Location

Second Department of Cardiology, University Hospital of Ioannina

Ioannina, Greece

Location

Heart Institute Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Toutouzas K, Benetos G, Voudris V, Drakopoulou M, Stathogiannis K, Latsios G, Synetos A, Antonopoulos A, Kosmas E, Iakovou I, Katsimagklis G, Mastrokostopoulos A, Moraitis S, Zeniou V, Danenberg H, Vavuranakis M, Tousoulis D. Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial. JACC Cardiovasc Interv. 2019 Apr 22;12(8):767-777. doi: 10.1016/j.jcin.2019.02.005. Epub 2019 Mar 27.

    PMID: 30928442DERIVED

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

  • Dimitrios Tousoulis, Professor

    University of Athens

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

January 14, 2015

First Posted

May 20, 2015

Study Start

May 1, 2015

Primary Completion

May 2, 2018

Study Completion

May 2, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

GR(3)IL(1)