{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:triluminate",
  "owner": "cardio",
  "kind": "study",
  "slug": "triluminate",
  "name": "TRILUMINATE Pivotal trial",
  "aliases": [
    "TRILUMINATE Pivotal",
    "TRILUMINATE"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A trial in 350 people with severe tricuspid regurgitation (a leaking valve between the right upper and lower chambers) and symptoms. It compared the TriClip device plus medicines against medicines alone. The combined result favored the device. Death, valve surgery and hospital stays for heart failure did not appear to differ between the groups, and the benefit came with better quality-of-life scores and less leaking. It was paid for by Abbott, the applicant for the device's US approval, and the registry lists masking of the outcome assessors only.",
  "summary_technical": "Registry NCT03904147 (Abbott Medical Devices lead sponsor, class industry, status active but not recruiting, estimated completion 2029-04). Randomized, parallel, masking single (outcomes assessor). The registry count (572) includes a single-arm group and a continued access study; the paper reports 350 randomized and enrolled. Abstract: win ratio 1.48 (95% confidence interval 1.06 to 2.13). Findings are not tabulated: the hierarchical composite has no outcome record in this atlas.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT03904147",
      "normalized_value": "NCT03904147",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "valvular-and-congenital-disease"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group trial of tricuspid transcatheter edge-to-edge repair plus medical therapy versus medical therapy alone. The registry records allocation as randomized, intervention model as parallel and masking as single (outcomes assessor), and adds a single-arm group and a continued access study.",
    "drug_phase": "not_applicable",
    "registry_statuses": [
      {
        "status": "ACTIVE_NOT_RECRUITING",
        "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2019-08-21",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2022-11-18",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
    },
    "completion_date": {
      "date": "2029-04",
      "type": "anticipated",
      "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
    },
    "results_first_posted": {
      "date": "2024-03-27",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "65 centers in the United States, Canada and Europe (abstract).",
      "snapshot": "cardio:pubmed-36876753-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 572,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct03904147-2026-10-14"
      },
      {
        "count": 350,
        "basis": "enrolled",
        "unit": "patients",
        "snapshot": "cardio:pubmed-36876753-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:triluminate-arm-device",
        "label": "TriClip plus medical therapy",
        "intervention": "cardio:triclip",
        "description": "Randomized device group: TriClip implantation with continued medical therapy at the physician's discretion (registry)."
      },
      {
        "id": "cardio:triluminate-arm-control",
        "label": "Medical therapy alone",
        "intervention": null,
        "description": "Randomized control group: continued medical therapy at the physician's discretion (registry). No separate intervention record exists for this comparison."
      }
    ],
    "findings": []
  },
  "content_digest": "02ac62f3e3a85bda6584cdef278f8f0643d8996ed982d14a893d59161848cf49",
  "review": {
    "content_digest": "02ac62f3e3a85bda6584cdef278f8f0643d8996ed982d14a893d59161848cf49",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Registry intervention: TriClip device",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:triclip",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03904147-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:abbott",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03904147-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "funded_by",
        "label": "Funder named in the abstract",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:abbott",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:pubmed-36876753-2026-10-14",
          "locator": "Abstract, CONCLUSIONS, sentence 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Lists tricuspid regurgitation as its condition; the registry's derived condition tree places it under Heart Valve Diseases",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:heart-valve-disease",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct03904147-2026-10-14",
          "locator": "derivedSection.conditionBrowseModule.ancestors[0].term"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Tests percutaneous tricuspid transcatheter edge-to-edge repair",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:transcatheter-edge-to-edge-repair",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:pubmed-36876753-2026-10-14",
          "locator": "Abstract, METHODS, sentence 1"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/triluminate/",
  "context_path": "api/v1/context/cardio--triluminate.md"
}