Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Recruiting
Phase 4
Interventional Study
Stage D Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- The Cleveland Clinic · Other
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About This Trial
The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to usual care oral vasodilator therapy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults (age ≥ 18 years)
2. Durable CF-LVAD for any indication
3. NYHA II to IV classification
4. LVEF \< 40%
5. Written informed consent
Exclusion Criteria:
1. Inability to comply with the conditions of the protocol
2. Any patient with durable CF-LVAD who has any one of the…
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