Aortic Valve StenosisHepaTAVINCT05422170
HEParin Antagonisation in Transcatheter Aortic Valve Implantation
An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Protamine Sulfate Overdose
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 1 Apr 2023
- Phase
- Observational
- 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
Study population: Patients with severe aortic valve stenosis undergoing transfemoral TAVI as best option
Who may be able to join
- Severe aortic valve Stenosis
- transfemoral TAVI as best therapy option
- unfractioned heparin for periprocedural anticoagulation
Who cannot join
- known hypersensitivity /allergy to unfractioned heparin or protamine
- acute systemic infection
- pre procedural started and ongoing intravenous therapy with unfractioned heparin
- severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
- refusal of the patient to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
Munich, Bavaria, D80636
Michael Joner, Prof, +498912180
Patrick Mayr, MD
About this study
Official title: Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation
Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Protamine Sulfate Overdose
- Keywords
- Anticoagulation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing transfemoral TAVI | Patients receiving 125 U/kg unfractioned heparin for periprocedural anticoagulation and 500U Protamine / 1000U Heparin at the end of the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Variability of the ROTEM CT(INTEM) after partial heparin reversal
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Mayr, Principal investigator, Deutsches Herzzentrum MünchenMichael Joner, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422170
- Sponsor's protocol ID
- GE IDE No. T00222
- Acronym
- HepaTAVI
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05422170
- Acronym / sponsor ID
- HepaTAVI / GE IDE No. T00222
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Protamine Sulfate Overdose
- Keywords
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 16 Jun 2022 (actual)
- 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.
Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing transfemoral TAVI | – | –Patients receiving 125 U/kg unfractioned heparin for periprocedural anticoagulation and 500U Protamine / 1000U Heparin at the end of the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe aortic valve stenosis undergoing transfemoral TAVI as best option
Key inclusion criteria (3 listed)
- Severe aortic valve Stenosis
- transfemoral TAVI as best therapy option
- unfractioned heparin for periprocedural anticoagulation
Key exclusion criteria (5 listed)
- known hypersensitivity /allergy to unfractioned heparin or protamine
- acute systemic infection
- pre procedural started and ongoing intravenous therapy with unfractioned heparin
- severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
- refusal of the patient to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint
Time frame: Periprocedural
Variability of the ROTEM CT(INTEM) after partial heparin reversal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Patrick Mayr principal investigator
Deutsches Herzzentrum München
Michael Joner principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Mayr, MD (+498912180, mayrp@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2022.