E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002906 |
E.1.2 | Term | Aortic stenosis |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 risk of ischaemic events. |
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E.2.2 | Secondary objectives of the trial |
To assess the whole complications of the procedure, including vascular complications. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must :
- be over 18 and carry a tight and symptomatic aortic stenosis
- have an indication for a balloon aortic valvuloplasty
- be informed about the study and have given his written informed consent |
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E.4 | Principal exclusion criteria |
Patients must not :
- have an absence of femoral surgical approach
- have a critical hemodynamic state, considered as outdrove for the treatment
- have a severe aortic failure
- be allergic to heparin
- have a contraindication to the use of heparin
- have a contraindication to local anaesthetic
- be treated by low molecular weight heparin in less than 12 hours before the valvuloplasty or by standard heparin in less than 4 hours before the valvuloplasty
- have a tight but not symptomatic aortic stenosis
- be pregnant, breast-feeding, with no rights from the national health insurance programme |
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E.5 End points |
E.5.1 | Primary end point(s) |
- the occurrence of a serious complication, whether it is a vascular, hemorrhagic or ischaemic complication
Are defined as serious :
- the vascular complications that involve a surgery
- the hemorrhagic complications that are equal or superior to the 3rd stage according to the BARC classification
- the ischaemic complications that involve the occurrence of acute ischemia, mesenteric ischemia, ischaemic CVA, heart stroke or systemic embolism |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At follow-up visits 2 and 3 (D1-D10 and D30 after the intervention) |
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E.5.2 | Secondary end point(s) |
- The occurence of any non-serious complications directly associated with the procedure
- The occurrence of complications non associated to the procedure |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At follow-up visits 2 and 3 (D1-D10 and D30 after the intervention) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |