Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05425459
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2022-06-13
Brief Title:
RESPONDER-HF Trial
Sponsor:
Corvia Medical
Organization:
Corvia Medical
Study Overview
Official Title:
Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction EF Heart Failure Protocol 2201
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
Multicenter Prospective Randomized Sham Controlled Double Blinded Clinical Trial with 11 randomization
Detailed Description:
Following supine bicycle exercise hemodynamic assessment to verify eligibility patients are sedated then randomized to the treatment or control group Patients in both arms will undergo placement of femoral venous access sheath
Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography ICE or transesophageal echocardiography TEE guided trans-septal puncture and Corvia Atrial Shunt implant procedure Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium
Patients will be evaluated at pre-specified time intervals and followed for 5 years
All patients will be unblinded after the 24 month follow up visit
Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography ICE or transesophageal echocardiography TEE guided trans-septal puncture and Corvia Atrial Shunt implant procedure Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium
Patients will be evaluated at pre-specified time intervals and followed for 5 years
All patients will be unblinded after the 24 month follow up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None