Last reviewed · How we verify
NCT01965015: VW-SP-1
The V-Wave Shunt: FIM Safety and Feasibility Study
NA trial testing Implantation of the V-Wave inter-atrial shunt in Congestive Heart Failure in 16 participants. Completed in 15 October 2017.
21 January 2016
Quick facts
| Lead sponsor | V-Wave Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 16 |
| Start date | 1 April 2014 |
| Primary completion | 21 January 2016 |
| Estimated completion | 15 October 2017 |
| Sites | 6 locations across Israel, Germany, Spain |
Drugs / interventions tested
- Implantation of the V-Wave inter-atrial shunt
Conditions studied
- Congestive Heart Failure — all drugs for Congestive Heart Failure →
Sponsor
V-Wave Ltd — full company profile →
Who can join
Adults 18 to 85, any sex, with Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant (baseline) status.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Percutaneous Strategies in Structural Heart Diseases: Focus on Chronic Heart Failure.
Filippini FB, Ribeiro HB, Bocchi E, Bacal F, et al · · 2023 · PMID 38126512 · DOI 10.36660/abc.20220496
Verify or expand the search:
- PubMed search for NCT01965015
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Congestive Heart Failure
Currently open trials in the same condition.
- NCT07008365 — The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure · Phase 3 · recruiting
- NCT06526884 — Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC) · NA · active not recruiting
- NCT06495892 — PVP-Guided Decongestive Therapy in HF 2 · Phase 4 · recruiting
- NCT06374277 — Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence · NA · recruiting
- NCT05971225 — Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe) · NA · recruiting
Other V-Wave Ltd trials
Trials by the same sponsor.
- NCT03838445 — Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH) · NA · recruiting
- NCT03499236 — Reducing Lung CongestIon Symptoms in Advanced Heart Failure · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01965015 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by V-Wave Ltd
- Last refreshed: 7 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01965015.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing