Reducing Lung CongestIon Symptoms in Advanced Heart Failure
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized treatment versus control (1:1). Control patients will be allowed to cross-over at the completion of the blinded phase. A parallel roll-in arm will enroll up to 2 patients per site in an open-label study.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: In the randomized cohort, participants, the clinical team, and research staff managing the patient after randomization will be blinded to study assignment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 400 patients will be randomized. Patients and all research staff managing the patients after randomization will be blin...
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 400 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.
Tracking Information
- NCT #
- NCT03499236
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stefan D Anker, MD, PhD University Medical Center Gottingen, Germany Principal Investigator: JoAnn Lindenfeld, MD Vanderbilt University Principal Investigator: Josep Rodés-Cabau, MD Université Laval (CRIUCPQ-ULaval) Principal Investigator: Gregg W Stone, MD Colombia University Medical Center
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