Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and potential benefits of single-side block of a nerve that connects to the intestines, liver and spleen called the "greater splanchnic nerve" for the treatments of patients with symptomatic heart failure who have normal pumping of the heart. The study will be performed in patients whose heart failure is not responding well to standard treatments and remain symptomatic.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device | Ablation of a single-side of the greater splanchnic nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE) | Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE) through 1-month follow up based on Independent Physician Adjudicator (IPA) assessment: Cardiovascular death; Embolic stroke; Device or procedure-related adverse cardiac events | 1 month |
| Mean change of PCWP with exercise after index procedure ablation as compared to baseline | Mean change of PCWP with exercise after index procedure ablation as compared to baseline | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality | Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality | 6 month |
| Change in average PCWP as compared to baseline |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Howard Levin, MD | Coridea, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolce | Prague | Czechia | ||||
| Tbilisi Heart and Vascular Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36175060 | Derived | Fudim M, Zirakashvili T, Shaburishvili N, Shaishmelashvili G, Sievert H, Sievert K, Reddy VY, Engelman ZJ, Burkhoff D, Shaburishvili T, Shah SJ. Transvenous Right Greater Splanchnic Nerve Ablation in Heart Failure and Preserved Ejection Fraction: First-in-Human Study. JACC Heart Fail. 2022 Oct;10(10):744-752. doi: 10.1016/j.jchf.2022.05.009. Epub 2022 Jul 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in average PCWP as compared to baseline |
| 1 month |
| Secondary Efficacy Endpoint | Change in the quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) between baseline and follow-up | 1, 3, 6 months |
| Secondary Efficacy Endpoint | Change in exercise tolerance as measured by the 6 minute walk test (6MWT) between baseline and follow-up | 1, 3, 6 months |
| Tbilisi |
| Georgia |
| Tbilisi Heart Center | Tbilisi | Georgia |