Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT01645202
Brief Summary:
A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis.
Detailed Description:
Study design: randomized open-label multicenter
Primary endpoint:
'Device success' as recently defined by VARC which is a 'technical' composite endpoint including:
1. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system,
2. Correct position of the device in the proper anatomical location,
3. Intended performance of the prosthetic heart valve (aortic valve area \> 1.2 cm2 and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, without moderate or severe prosthetic valve AR) and
4. Only one valve implanted in the proper anatomical location.
Secondary endpoints:
* 30-day-combined safety endpoint which is a combined endpoint defined by VARC as:
1. All cause mortality,
2. Major stroke,
3. Life threatening (or disabling) bleeding,
4. Acute kidney injury-Stage 3 (including renal replacement therapy),
5. Periprocedural myocardial infarction,
6. Major vascular complications and
7. Repeat procedure for valve-related dysfunction (surgical or interventional therapy). \*
* Combined efficacy endpoint at 1 year which is a composite endpoint defined by VARC as:
1. All cause mortality between 30 days and one year,
2. Failure of current therapy for aortic stenosis, requiring hospitalization for symptoms of valve-related or cardiac decompensation and
3. Prosthetic heart valve dysfunction (aortic valve area \< 1.2 cm2 and mean aortic valve gradient \> 20 mmHg or peak velocity \> 3 m/s or moderate or severe prosthetic valve AR). \*
* Cardiovascular mortality as defined by VARC at 1 month, 6 and 12 months. \*
* Major adverse cardiovascular and cerebrovascular events (MACCE): myocardial infarction, cardiac or vascular surgery and stroke at 30 days, 6 \& 12 months.
* Rehospitalization for heart failure at 12 months
* Quality of life (assessed with the Euro5Qual-questionnaire) at 12 months
* NYHA-class improvement at 30 days, 6 and 12 months
* Vascular complication as defined by VARC at 30 days.
* Post-procedural pacemaker implantation at 1 month
* Major or minor Bleeding at 30 days as defined be VARC.
Study:
NCT01645202
Study Brief:
Protocol Section:
NCT01645202