Aortic Stenosis, Non-rheumaticPhase 4HEPAVALVNCT01823393
Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure
A Phase 4 study testing Heparin and NaCl in people with Aortic Stenosis, Non-rheumatic, run by University Hospital, Montpellier at 1 site in France.
Trial summary
To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Non-rheumatic
- What is being tested?
- Heparin and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2013to 22 Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18
- carry a tight and symptomatic aortic stenosis
- have an indication for a ballon aortic valvuloplasty
- Subject have signed his written informed consent
Who cannot join
- Have an absence of femoral surgical approach
- have a criticial hemodynamic state, considered as outdrove for the treatment
- have a severe aortic failure
- allergia to heparin
- contraindication to heparin or/and local anaesthetic
- be treted by low molecular weight heparin in less than 12 hoursbefore the intervention or by standard heparin in less than 4 hours before the valvulopasty
- have a tight but not symptomatic aortic stenosis
Trial locations and contacts
1 site in 1 country.
About this study
To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.
- Conditions
- Aortic Stenosis, Non-rheumatic
- Being tested
- Heparin, NaCl
- Keywords
- balloon aortic valvuloplasty indication, heparin, hemorrhagic, ischemic
- Medical subject headings
- Aortic Valve Stenosis, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Also called Unfractioned heparin
Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure
NaClDrug
Also called placebo
valvuloplasty is performed without heparin (placebo injection)
| Study group | Role | What they receive |
|---|---|---|
| Heparin | Experimental | injection of unfractionated heparin (50 IU / kg) Receives: Drug: Heparin |
| NaCl | Placebo comparator | without heparin Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious complication : vascular, hemorrhagic or ischaemic complication
Measured: Up to10 days after the valvuloplasty (D1-D10 after the intervention)
Secondary outcomes (2)
Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)
Non serious complication is complication directly associated with the valvuloplasty which could be vascular complications medically treated (compression), BARC 2 hemorrhage, general procedure complications
Measured: up to30 days after the valvuloplasty (until D30 after intervention)
number of a serious complication : vascular, hemorrhagic or ischaemic complication
Measured: up to 30 days after valvuloplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start24 Jan 2013
- Primary completion22 Oct 2016
- Study completion22 Oct 2016
Why it stopped: Difficulty of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis, Non-rheumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, PU PH, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823393
- Sponsor's protocol ID
- 9026
- Acronym
- HEPAVALV
- Status last verified
- Oct 2021
- First submitted
- 22 Mar 2013
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Akodad M, Labour J, Nogue E, Delseny D, Macia JC, Gervasoni R, Lattuca B, Nagot N, Roubille F, Cayla G, Leclercq F. Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study. Int J Cardiol Heart Vasc. 2022 Jan 18;39:100951. doi: 10.1016/j.ijcha.2021.100951. eCollection 2022 Apr.
PubMed 35402691
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure
- ClinicalTrials.gov ID
- NCT01823393
- Acronym / sponsor ID
- HEPAVALV / 9026
- Conditions
- Aortic Stenosis, Non-rheumatic
- Keywords
- balloon aortic valvuloplasty indication, heparin, hemorrhagic, ischemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of inclusion
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Jan 2013 (actual)
- Primary completion
- 22 Oct 2016 (actual)
- Study completion
- 22 Oct 2016 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin | Experimental | Drug: Heparininjection of unfractionated heparin (50 IU / kg) |
| NaCl | Placebo comparator | Drug: NaClwithout heparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be over 18
- carry a tight and symptomatic aortic stenosis
- have an indication for a ballon aortic valvuloplasty
- Subject have signed his written informed consent
Key exclusion criteria (7 listed)
- Have an absence of femoral surgical approach
- have a criticial hemodynamic state, considered as outdrove for the treatment
- have a severe aortic failure
- allergia to heparin
- contraindication to heparin or/and local anaesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinAlso: Unfractioned heparinValvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure | Drug | Heparin |
| NaClAlso: placebovalvuloplasty is performed without heparin (placebo injection) | Drug | NaCl |
Primary outcome
Number of serious complication : vascular, hemorrhagic or ischaemic complication
Time frame: Up to10 days after the valvuloplasty (D1-D10 after the intervention)
2 secondary outcomes
Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)
Time frame: up to30 days after the valvuloplasty (until D30 after intervention)
number of a serious complication : vascular, hemorrhagic or ischaemic complication
Time frame: up to 30 days after valvuloplasty
Results and safety
The study was stopped early (reason given: Difficulty of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 35402691Akodad M, Labour J, Nogue E, Delseny D, Macia JC, Gervasoni R, Lattuca B, Nagot N, Roubille F, Cayla G, Leclercq F. Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study. Int J Cardiol Heart Vasc. 2022 Jan 18;39:100951. doi: 10.1016/j.ijcha.2021.100951. eCollection 2022 Apr.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Leclercq, PU PH principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin and NaCl in people with Aortic Stenosis, Non-rheumatic, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious complication : vascular, hemorrhagic or ischaemic complication (time frame: Up to10 days after the valvuloplasty (D1-D10 after the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01823393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.