Figures cited from live ClinicalTrials.gov records NCT07244939 and NCT05052684 and the published bioaccess® Brazil country page, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the institute and trials those records support. bioaccess® is not listed on either NCT and no bioaccess® page claims Cephea or Leaflex at InCor.
If you searched InCor Cephea, Instituto do Coração HCFMUSP clinical trial, InCor first-in-human mitral, or “go direct to InCor,” you followed a facility name ClinicalTrials.gov published. Instituto do Coração (InCor) — Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — is a real cardiovascular site. It is not the operator of the ANVISA file.
bioaccess®’s position is simple and it is not adversarial: InCor is the site. The First-in-Human CRO still owns ANVISA / CEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if São Paulo is not the only fit. Sponsors who skip the CRO and email the institute still have to rebuild that stack. The hospital does not become a CRO because Abbott or Pi-cardia listed it.
This page does not clone clinical trials in Brazil. That page stays the country system — including the published note that São Paulo’s Hospital das Clínicas is one of the largest medical complexes in Latin America. This page answers the InCor-named query.
What the public NCT file actually says
NCT07244939 — Cephea South America Feasibility Study. Lead sponsor: Abbott Medical Devices. Organization study ID: ABT-CIP-10554. Status: RECRUITING. Actual start 17 June 2025; estimated completion September 2028; estimated enrollment 20; interventional, single-group, no masking; intervention: Cephea Mitral Valve System; conditions: mitral regurgitation and mitral stenosis. Objective on the brief summary: preliminary safety and effectiveness of the Cephea Mitral Valve System for symptomatic mitral valve disease (regurgitation, stenosis, or mixed) when the site heart team judges transcatheter therapy more appropriate than open surgery. Primary outcomes listed: freedom from all-cause mortality; reduction of MR to ≤ Grade I. Key inclusion: MR ≥ Grade III and/or severe mitral stenosis (area ≤ 1.5 cm²), LVEF ≥ 30%. The São Paulo row is Instituto do Coracao (InCor) – HCFMUSP, status RECRUITING, principal investigator Alexandre Abizaid, contact João Mourão. Sister South America rows on the same record: Instituto Nacional del Torax and Hospital Clinico San Borja Arriarán, both Santiago, Chile, both recruiting. Study director: Barathi Sethuraman, Abbott Structural Heart.
NCT05052684 — The Leaflex™ Brazilian Standalone Study. Lead sponsor: Pi-cardia. Status: TERMINATED. Why stopped: “Reprioritization of attention and resources by Sponsor.” Actual start 3 October 2022; actual completion 14 November 2024; actual enrollment 1; intervention: Leaflex™ Performer; condition: aortic valve stenosis; single-group safety and performance design. Facility listed: Instituto do Coração FMUSP Centro de Pesquisa, São Paulo, Brazil. Study director: Hadas Givon, Pi-cardia. No site PI is named on the live location row.
Neither record names a CRO. That is how a sponsor finds InCor without finding the operator. We will not claim bioaccess® ran either study.
InCor is a site. The CRO is the operator.
InCor can provide structural-heart rooms, imaging, and an investigator of Abizaid’s public stature. That is necessary. It is not sufficient for a first-in-human or early-feasibility device study a U.S. board expects to survive FDA review.
- ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation with a São Paulo operator is not that dossier.
- CEP. Institutional ethics under Law 14874; published country-page cap of 30 business days. The CEP is tied to the host institution once the site is chosen — which is why “we already have InCor” still leaves the packet to write.
- Investigational import into Brazil is a separate permit from the trial authorization and from later ANVISA market registration (RDC 751/2022 / BRH). See importer of record.
- ISO 14155 monitoring, EDC, SAE, TMF — including if you later add the Chilean rows on the Cephea record or a Colombian alternative.
- 21 CFR 812.28 — eligibility of foreign data for FDA submission and review, not clearance. See OUS FIH and FDA IDE.
Site versus CRO
| Workstream | What InCor / HCFMUSP typically owns | What the CRO still owns |
|---|---|---|
| Structural-heart capability | OR / hybrid room, imaging, implanting physicians, ICU | Protocol feasibility, training, device accountability |
| Ethics | Institutional CEP calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not a hallway conversation | ANVISA clinical-investigation dossier (RDC 837/2023) |
| Import | Receiving dock, storage if contracted | Importer of record, permits |
| Quality | Hospital quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they ran | 21 CFR 812.28 narrative |
| Country optionality | One São Paulo complex (plus Chile on Cephea) | Colombia and the rest of the bioaccess® platform |
ANVISA in one screen (from the country page, not a new median)
Published on clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837; per-patient $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority; trial authorization and market registration are separate workstreams. Those figures are country-page figures. They are not InCor-only quotes.
Chile on the same Cephea record is not InCor
NCT07244939 is a South America feasibility, not a São Paulo-only story. Instituto Nacional del Torax (PI Jorge Sandoval) and Hospital Clinico San Borja Arriarán (PI Gabriel Maluenda) are recruiting in Santiago. That is another reason “email InCor” is not a study. A multi-country structural-heart file still needs one operator for import, monitoring, and the English dataset — whether the next case is in São Paulo or Santiago. We are not publishing Chilean intercepts in this wave; we are refusing to pretend those rows do not exist.
Colombia is still on the map
bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess®. A Cephea São Paulo search is not an instruction to abandon INVIMA. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Frequently asked questions
Can I contract InCor directly?
You can try. The institute can discuss investigator interest, local procedure costs, and CEP calendars. It cannot become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because Abbott listed Alexandre Abizaid. Contract the CRO; let the CRO activate InCor as the site.
Did bioaccess® run Cephea or Leaflex at InCor?
No public bioaccess® page says so. We will not invent that claim. PercAssist São Paulo remains an unsourced hospital-level name on our press hub and is not assigned to InCor here.
Leaflex enrolled one patient and stopped. Does that smear InCor?
No. The live record says the sponsor reprioritized. That is a sponsor decision, not a reason to attack the institute. Do not smear the site.
If I already have InCor, what does the CRO still do?
Regulatory-fit (Brazil vs Colombia vs a Chile-plus-Brazil design); the ANVISA / CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one São Paulo room is not enough.
Is Colombia still an option?
Yes. Brazil’s published per-patient band is higher than Colombia’s published $15,000–$25,000 band on the Panama/Colombia comparison. Colombia still wins for some indications on INVIMA Level 4 and the published site network. Lock the building after the review.
Next step
Contact bioaccess® · First-in-Human CRO · Brazil · CT.gov hub · Dante Pazzanese · Albert Einstein · CRO in Colombia.
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