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NCT07129421: EMBLOK II
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
NA trial testing EMBLOK™ Embolic Protection System ("EMBLOK EPS") in AORTIC VALVE DISEASES in 560 participants. Not yet recruiting.
31 January 2027
Quick facts
| Lead sponsor | Emblok, Inc. |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 560 |
| Start date | 21 October 2025 |
| Primary completion | 31 January 2027 |
| Estimated completion | 15 March 2027 |
Drugs / interventions tested
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
Conditions studied
- AORTIC VALVE DISEASES — all drugs for AORTIC VALVE DISEASES →
- Aortic Valve Stenosis and/or Insufficiency — all drugs for Aortic Valve Stenosis and/or Insufficiency →
- Aortic Valve Regurgitation — all drugs for Aortic Valve Regurgitation →
- Aortic Valve Replacement — all drugs for Aortic Valve Replacement →
Sponsor
Emblok, Inc.
Who can join
18 and older, any sex, with AORTIC VALVE DISEASES or Aortic Valve Stenosis and/or Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR). The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems. This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 560 subjects undergoing TAVR at up to 40 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days, and diffusion-weighted magnetic resonance imaging (DW-MRI) follow-up at 24 to 36 hours post-procedure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07129421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EMBLOK™ Embolic Protection System ("EMBLOK EPS")
Trials testing the same drug.
- NCT05295628 — Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR · NA · active not recruiting
Other recruiting trials for AORTIC VALVE DISEASES
Currently open trials in the same condition.
- NCT06818084 — TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System · Phase 4 · recruiting
- NCT06830499 — Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China · recruiting
- NCT07476703 — Expanded Studies on the SCAPIS Stockholm Reexamination Cohort · recruiting
- NCT04258488 — Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replac · Phase 4 · recruiting
Other Emblok, Inc. trials
Trials by the same sponsor.
- NCT05295628 — Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR · NA · active not recruiting
- NCT03130491 — European Study Evaluating the EMBLOK Embolic Protection System During TAVR · NA · completed
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 NCT07129421 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Emblok, Inc.
- Last refreshed: 19 August 2025
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/NCT07129421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing