Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-14 @ 5:53 AM
Study NCT ID:
NCT01645202
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2012-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial
Sponsor:
Segeberger Kliniken GmbH
Organization:
Study Overview
Official Title:
A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHOICE
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: