{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:evolut-low-risk",
  "owner": "cardio",
  "kind": "study",
  "slug": "evolut-low-risk",
  "name": "Evolut Low Risk trial",
  "aliases": [
    "Evolut Low Risk",
    "Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A trial that compared TAVR (with a self-expanding Medtronic valve) against open-heart surgery in 1468 people with severe aortic stenosis who were at low risk from surgery. After two years, the rate of death or disabling stroke with TAVR was no worse than with surgery. TAVR had more pacemakers and more aortic regurgitation at 30 days. It was paid for by Medtronic, the applicant for the valve's US approval, and the registry lists no masking.",
  "summary_technical": "Registry NCT02701283 (Medtronic Cardiovascular lead sponsor, class industry, status active but not recruiting, estimated completion 2029-06). Randomized, parallel, no masking, treatment. Abstract: Bayesian analysis of the 24-month death or disabling stroke end point when 850 patients had reached 12-month follow-up; 5.3% versus 6.7%. The registry also covers a continued access study, which is why its count (2223) is larger than the 1468 randomized in the paper. The start date has no type in the registry. 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": "NCT02701283",
      "normalized_value": "NCT02701283",
      "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 noninferiority trial of TAVR with a self-expanding supraannular 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-nct02701283-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2016-03",
      "type": null,
      "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2021-04",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
    },
    "completion_date": {
      "date": "2029-06",
      "type": "anticipated",
      "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
    },
    "results_first_posted": {
      "date": "2021-09-09",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      },
      {
        "code": "NZ",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 2223,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct02701283-2026-10-14"
      },
      {
        "count": 1468,
        "basis": "randomized",
        "unit": "patients",
        "snapshot": "cardio:pubmed-30883053-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:evolut-low-risk-arm-tavr",
        "label": "TAVR with a Medtronic self-expanding valve",
        "intervention": "cardio:corevalve-evolut",
        "description": "Treatment with the Medtronic CoreValve System or the Medtronic CoreValve Evolut R System (registry); a self-expanding supraannular bioprosthesis (abstract)."
      },
      {
        "id": "cardio:evolut-low-risk-arm-savr",
        "label": "Surgical aortic valve replacement",
        "intervention": "cardio:surgical-aortic-valve-replacement",
        "description": "Commercial surgical aortic valve replacement with a commercially approved surgical bioprosthesis (registry)."
      }
    ],
    "findings": []
  },
  "content_digest": "284c281c70e64df747acb69cab738c4a35ea9c1e29d3a1ca1a715291749cc459",
  "review": {
    "content_digest": "284c281c70e64df747acb69cab738c4a35ea9c1e29d3a1ca1a715291749cc459",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Registry intervention: Medtronic transcatheter aortic valve replacement systems",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:corevalve-evolut",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02701283-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].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-nct02701283-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[1].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Registry condition: aortic valve 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-nct02701283-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "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:medtronic",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02701283-2026-10-14",
          "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:medtronic",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:pubmed-30883053-2026-10-14",
          "locator": "Abstract, CONCLUSIONS, sentence 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Tests transcatheter aortic valve replacement",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:tavr",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02701283-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/evolut-low-risk/",
  "context_path": "api/v1/context/cardio--evolut-low-risk.md"
}