REDUCE LAP-HF RANDOMIZED TRIAL I
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02600234|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2015
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Inter-Atrial Shunt Device Other: Intracardiac Echo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2022|
Experimental: Treatment with Inter-Atrial Shunt Device
Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.
Device: Inter-Atrial Shunt Device
An implantable device placed in the interatrial septum
Other Name: IASD
Placebo Comparator: Control
Once all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.
Other: Intracardiac Echo
Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.
- The change in supine exercise PCWP from baseline [ Time Frame: 1 Month Post Procedure ]
- The composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) [ Time Frame: 1 Month Post Procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600234
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