Figures cited from the live ClinicalTrials.gov record NCT06113354 (last update posted 1 September 2026; first posted 2 November 2023) and the published bioaccess® Brazil country page, verified 1 September 2026. General information, not legal or regulatory advice. Confirm current ANVISA, CEP, and FDA rules with qualified advisers. We name only the facility, investigators, and trial those sources support. Polares Medical is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.
If you searched Fundação Universitaria de Cardiologia clinical trial, Porto Alegre MRace, Polares Medical Brazil EFS, EXPLORE MRace BR, or “go direct to the Porto Alegre mitral site,” you followed a facility string ClinicalTrials.gov still publishes on 1 September 2026. Fundação Universitaria de Cardiologia in Porto Alegre, Rio Grande do Sul, is a real cardiology facility on that record. It is not the operator of the ANVISA file.
bioaccess®’s position is simple and it is not adversarial: Fundação Universitaria de Cardiologia 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 Porto Alegre is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A recruiting location row does not become a CRO.
This page is the intercept for the Porto Alegre query. It does not clone clinical trials in Brazil. That page stays the country operating system. The São Paulo sister row on the same NCT already has its own intercept: InCor HCFMUSP. Do not merge Porto Alegre into InCor. PercAssist AVANXA remains a separate city-plus-KOL intercept with no hospital invented: PercAssist AVANXA Brazil.
Why the hospital name wins the search — and why that is not a CRO
NCT06113354 is an industry device early-feasibility listing. Brief title: EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant. Official title: Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant Brazil (EXPLORE MRace – BR). Acronym: EXPLORE MRace. Lead sponsor: Polares Medical SA, class INDUSTRY. Collaborator listed: Polares Medical, Inc. only. No CRO is listed.
Design on the 1 September 2026 snapshot: interventional; single-group registry; no masking; primary purpose DEVICE_FEASIBILITY; phase N/A; estimated enrollment 10; status RECRUITING. Actual start 8 April 2024. Study first posted 2 November 2023; last update posted 1 September 2026. Condition: mitral valve disease. Intervention, in the registry’s words: Transcatheter mitral valve repair (MRace Implant and Delivery System), other name TMVr — femoral-vein / transseptal placement of a prosthesis intended to augment the posterior mitral leaflet.
Location rows currently published:
- Fundação Universitaria de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil — RECRUITING. Site contact named as Rogerio Leite, MD. Principal investigator listed as Roberio Leite, MD (names as published on ClinicalTrials.gov; we will not invent a single merged identity or invent a hospital email beyond what the public row shows).
- InCor – Instituto do Coração do Hospital das Clínicas da FMUSP, São Paulo, Brazil — RECRUITING. Principal investigators / contacts named include Alexandre Abizaid, MD and Fabio Sandoli de Brito, MD. Already intercepted on incor-hcfmosp-fih.
Central contact on the record: Kristine Orosz, Polares Medical. Study director: Robin Eckert, Polares Medical. The brief summary still says “up to 10 patients at one (1) center in Brazil,” while the locations module lists two recruiting Brazilian facilities. We report both facts as published. We do not invent which building ran which case.
Read the record as it is. Primary purpose is DEVICE_FEASIBILITY and the title says Early Feasibility. Estimated n=10 is classic EFS scale. No CRO collaborator appears. That is the site-direct leak: a sponsor searching MRace, Polares, or Porto Alegre cardiology now lands on a named hospital with InCor already known and Fundação Universitaria still without a dedicated public intercept until this page.
Porto Alegre is a site. The CRO is the operator.
A Porto Alegre cardiology foundation can provide imaging, structural-heart rooms, and an investigator the registry already named. That is necessary. It is not sufficient for an early-feasibility TMVr study a U.S. board expects to survive FDA review — including a later IDE conversation after OUS feasibility.
What a site can typically do when a sponsor “goes direct”:
- Discuss investigator interest and procedural feasibility for a mitral protocol — when that service is available and appropriate for your device, which is not automatic.
- Share institutional CEP calendars and hospital research rules.
- Quote procedure, visit, and local staffing costs for the cases they will physically run.
What the site is not built to own for an investigational device:
- ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation in Porto Alegre 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 Fundação Universitaria” 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 for clinical trial devices in Latin America.
- Clinical trial insurance. Required. We will not invent a Porto Alegre-only premium here.
- ISO 14155 monitoring, EDC, SAE reporting, and the TMF — including if you later use the InCor row on the same NCT or add Colombia.
- The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance. See OUS FIH and FDA IDE.
- Multi-country optionality. If Porto Alegre enrollment, imaging, or the indication later needs São Paulo capacity already on this NCT, Bogotá, or Panama City, a single-hospital MSA will not stretch.
Going direct to Fundação Universitaria de Cardiologia is how you confirm a room. It is not how you open an investigational file.
Site versus CRO
| Workstream | What Fundação Universitaria (site) typically owns | What the CRO still owns |
|---|---|---|
| Procedure | OR / hybrid room, imaging, mitral caseload, local staff | Protocol fit, training, MRace-class device accountability |
| Ethics | Institutional CEP calendar and local rules | Packet, ICF, IB alignment, deficiency cycle |
| National authority | Not the permit holder by being listed on an NCT | ANVISA clinical-investigation dossier (RDC 837/2023) |
| Import | Receiving and storage if contracted | Importer of record |
| Quality | Hospital quality and the case | ISO 14155 monitoring, EDC, SAE, TMF |
| FDA conversation | Source documents from cases they run | 21 CFR 812.28 narrative — eligibility, not clearance |
| Country optionality | One Porto Alegre building (plus InCor on the same NCT) | Colombia (INVIMA) and the rest of the bioaccess® platform |
How ANVISA and CEP sit next to the hospital
Use clinical-trials-brazil for the full pathway. Facts a sponsor searching this hospital needs on one screen, already published there and not re-averaged here:
- Combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837.
- Published per-patient range $20,000–$35,000; 15+ pre-qualified sites; ANVISA is a WHO-listed authority.
- Trial authorization and market registration are separate workstreams.
- Under 21 CFR 812.28, foreign clinical data from Brazil is eligible for FDA submission and review when studies are conducted under ISO 14155 with proper ANVISA authorization and CEP ethics approval. Eligibility is not a guarantee of clearance or approval.
- bioaccess®’s published Brazil cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study. Headline ~40% faster / ~30% lower per-patient figures on llms.txt and LATAM FIH benchmarks 2026 are the same class of estimate.
We will not invent a Fundação Universitaria-only day-count. Ask for a protocol-specific calendar. A hospital email is not an ANVISA approval.
What the Polares public file actually supports — and what it does not
- Device: MRace Implant and Delivery System (TMVr / posterior leaflet restoration), as described on NCT06113354.
- Sponsor: Polares Medical SA (industry). Collaborator: Polares Medical, Inc. No CRO named.
- Sites: Fundação Universitaria de Cardiologia, Porto Alegre (this page); InCor HCFMUSP, São Paulo (existing intercept).
- Design: interventional DEVICE_FEASIBILITY early feasibility; estimated n=10; actual start 8 April 2024; RECRUITING on the 1 September 2026 last-update snapshot.
- Named investigators (as published): Rogerio Leite, MD (Porto Alegre contact); Roberio Leite, MD (Porto Alegre PI listing); Alexandre Abizaid, MD and Fabio Sandoli de Brito, MD (InCor).
- Not claimed here: that the NCT named bioaccess®; that Polares Medical is a bioaccess® client; that we have Polares outcomes; that the brief summary’s “one center” line erases the second location row; that Porto Alegre is the same building as InCor, Dante Pazzanese, or PercAssist AVANXA.
Sister São Paulo intercepts stay on their own buildings: InCor and Instituto Dante Pazzanese. Do not merge them into Porto Alegre.
What the CRO still does after you have a hospital name
- Regulatory-fit, not tourism. Brazil is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
- Protocol, IB, ICF, insurance, and the ANVISA / CEP packet.
- Importer of record and device accountability across Porto Alegre and, if used, the InCor row.
- ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
- Optionality if one Rio Grande do Sul room is not enough.
The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.
Frequently asked questions
Can I contract Fundação Universitaria de Cardiologia directly?
You can try. The facility 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 Polares listed Porto Alegre. Contract the CRO; let the CRO activate the site.
Did bioaccess® run EXPLORE MRace / Polares in Brazil?
No public bioaccess® page says so. We will not invent that claim. This page intercepts the search; it does not claim the study.
InCor is on the same NCT. Why a separate Porto Alegre page?
Because sponsors search the facility string they see. InCor already has incor-hcfmosp-fih. Fundação Universitaria de Cardiologia is a different building in a different city. Linking is correct. Duplicating the InCor slug is not.
If I already have Porto Alegre, what does the CRO still do?
Regulatory-fit (Brazil vs Colombia vs a multi-site Brazil design that already includes InCor on this NCT); the ANVISA / CEP packet; insurance; import; contracts and activation; ISO 14155 and the 812.28 narrative; optionality if one Porto Alegre room is not enough.
Is Colombia still an option?
Yes. bioaccess® still runs trials in Colombia. A Porto Alegre EFS search is not an instruction to abandon INVIMA.