{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:partner-3",
  "owner": "cardio",
  "kind": "study",
  "slug": "partner-3",
  "name": "PARTNER 3 trial",
  "aliases": [
    "PARTNER 3",
    "P3",
    "PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A trial that compared TAVR (with the SAPIEN 3 valve) against open-heart surgery in 1000 people with severe aortic stenosis who were at low risk from surgery. After one year, fewer people in the TAVR group had died, had a stroke or had gone back to hospital. It was paid for by Edwards Lifesciences, the applicant for the valve's US approval, and the registry lists no masking.",
  "summary_technical": "Registry NCT02675114 (Edwards Lifesciences lead sponsor, class industry, status active but not recruiting, estimated completion 2029-12). Randomized, parallel, no masking, treatment. Abstract: noninferiority margin 6 percentage points, as-treated analysis; primary composite at 1 year 8.5% versus 15.1% (hazard ratio 0.54). Findings are not tabulated because the primary 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": "NCT02675114",
      "normalized_value": "NCT02675114",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "valvular-and-congenital-disease"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group, open-label trial of TAVR with a balloon-expandable valve versus surgical aortic valve replacement. The registry records allocation as randomized, intervention model as parallel and masking as none.",
    "drug_phase": "not_applicable",
    "registry_statuses": [
      {
        "status": "ACTIVE_NOT_RECRUITING",
        "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2016-03",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2020-11-16",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
    },
    "completion_date": {
      "date": "2029-12",
      "type": "anticipated",
      "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
    },
    "results_first_posted": {
      "date": "2021-12-02",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
      },
      {
        "code": "NZ",
        "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "71 centers (abstract); the registry lists sites in five countries.",
      "snapshot": "cardio:pubmed-30883058-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 1000,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct02675114-2026-10-14"
      },
      {
        "count": 1000,
        "basis": "randomized",
        "unit": "patients",
        "snapshot": "cardio:pubmed-30883058-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:partner-3-arm-tavr",
        "label": "TAVR with the SAPIEN 3 valve",
        "intervention": "cardio:sapien-3",
        "description": "Transcatheter aortic valve replacement with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System (registry), placed through the femoral artery with a balloon-expandable valve (abstract)."
      },
      {
        "id": "cardio:partner-3-arm-savr",
        "label": "Surgical aortic valve replacement",
        "intervention": "cardio:surgical-aortic-valve-replacement",
        "description": "Surgical aortic valve replacement with a commercially available bioprosthetic valve (registry)."
      }
    ],
    "findings": []
  },
  "content_digest": "f6fc0de03113228fef457adea274334b5a882f5009950df33e2be0182e404267",
  "review": {
    "content_digest": "f6fc0de03113228fef457adea274334b5a882f5009950df33e2be0182e404267",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Registry intervention: SAPIEN 3 THV",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:sapien-3",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02675114-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[1].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Registry comparison: SAVR",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:surgical-aortic-valve-replacement",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02675114-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Registry condition: aortic stenosis",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:aortic-stenosis",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02675114-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Part of the primary outcome measure",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "core:outcome-death-any-cause",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02675114-2026-10-14",
          "locator": "protocolSection.outcomesModule.primaryOutcomes[0].measure"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Part of the primary outcome measure",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "core:outcome-stroke",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02675114-2026-10-14",
          "locator": "protocolSection.outcomesModule.primaryOutcomes[0].measure"
        },
        "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:edwards-lifesciences",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02675114-2026-10-14",
          "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:edwards-lifesciences",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:pubmed-30883058-2026-10-14",
          "locator": "Abstract, CONCLUSIONS, sentence 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/partner-3/",
  "context_path": "api/v1/context/cardio--partner-3.md"
}