NCT00710775

Brief Summary

The study will be conducted in patients who are undergoing surgical aortic valve replacement on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to removal of the valve, the native valve will be dilated using a standard valve dilation balloon. The Heart Leaflet Technologies(HLT- Heart Leaflet Technologies Inc.) aortic valve device will be released in the native valve and measurements will be taken of the device relative to the anatomic structures of the heart. Once completed, the implant is removed from the native valve and the surgical valve replacement procedure is completed. The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate for patients with aortic valve stenosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 12, 2009

Status Verified

May 1, 2008

Enrollment Period

1.1 years

First QC Date

June 27, 2008

Last Update Submit

October 9, 2009

Conditions

Aortic Valve StenosisEndovascular Aortic Valve Replacement

Keywords

Aortic valve stenosisHeart surgeryEndovascular techniques

Outcome Measures

Primary Outcomes (1)

  • geometrical evaluation of HLT pliability to patient's native aortic valve

    during surgery procedure

Study Arms (1)

1

OTHER

Patients undergoing surgical aortic valve replacement on cardiopulmonary bypass.

Procedure: surgical replacement of the aortic stenotic valve

Interventions

surgical replacement of the aortic stenotic valvePROCEDURE

Prior to surgical removal of the aortic valve, the native valve will be dilated under direct vision of the surgeon using a standard valve dilation balloon. The HLT valve will be loaded into a short version of the delivery catheter system and the catheter will be passed across the native valve.Measurements will be taken of the device relative to the anatomic structures of the heart. Once complete, the implant is removed from the native valve and the surgical valve replacement procedure is completed.

Also known as: AVR (aortic valve replacement)
1

Eligibility Criteria

Age75 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients undergoing aortic valve replacement for aortic valve stenosis with a preoperative valve area \< 0.9 cm2.
  • A preoperative echocardiogram where the aortic annulus diameter can be measured and is between 19 and 25 mm internal diameter.
  • Age 75 to 80 years

You may not qualify if:

  • Emergency valve surgery
  • Significant ascending aortic disease (atheroma, extensive calcification, dissection) as assessed by the operating surgeon
  • Ostial coronary obstruction \> 25% diameter stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino- University of Milan, Italy

Milan, 20138, Italy

RECRUITING

Related Publications (3)

  • Ghanbari H, Kidane AG, Burriesci G, Bonhoeffer P, Seifalian AM. Percutaneous heart valve replacement: an update. Trends Cardiovasc Med. 2008 May;18(4):117-25. doi: 10.1016/j.tcm.2008.02.002.

    PMID: 18555184BACKGROUND

  • Webb JG. Percutaneous aortic valve replacement. Curr Cardiol Rep. 2008 Mar;10(2):104-9. doi: 10.1007/s11886-008-0019-z.

    PMID: 18417010BACKGROUND

  • Rosengart TK, Feldman T, Borger MA, Vassiliades TA Jr, Gillinov AM, Hoercher KJ, Vahanian A, Bonow RO, O'Neill W; American Heart Association Council on Cardiovascular Surgery and Anesthesia; American Heart Association Council on Clinical Cardiology; Functional Genomics and Translational Biology Interdisciplinary Working Group; Quality of Care and Outcomes Research Interdisciplinary Working Group. Percutaneous and minimally invasive valve procedures: a scientific statement from the American Heart Association Council on Cardiovascular Surgery and Anesthesia, Council on Clinical Cardiology, Functional Genomics and Translational Biology Interdisciplinary Working Group, and Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2008 Apr 1;117(13):1750-67. doi: 10.1161/CIRCULATIONAHA.107.188525. Epub 2008 Mar 10.

    PMID: 18332270BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Paolo Biglioli, MD

    Centro Cardiologico Monzino-University of Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Biglioli, MD

CONTACT

+39/02/5800paolo.biglioli@ccfm.it

Luca Dainese, MD

CONTACT

+39/02/5800luca.dainese@ccfm.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 4, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 12, 2009

Record last verified: 2008-05

Locations

IT(1)