{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:early-tavr",
  "owner": "cardio",
  "kind": "study",
  "slug": "early-tavr",
  "name": "EARLY TAVR",
  "aliases": [
    "EARLY TAVR",
    "EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A trial in 901 people aged 65 or older with severe aortic stenosis but no symptoms. It compared early TAVR (with the SAPIEN 3 valve) against clinical surveillance. Fewer people in the TAVR group had a death, stroke or unplanned hospital stay. Death occurred in 8.4% and 9.2% of the two groups, and the abstract gives no test for it. It was paid for by Edwards Lifesciences, the applicant for the valve's US approval, and the registry lists no masking.",
  "summary_technical": "Registry NCT03042104 (Edwards Lifesciences lead sponsor, class industry, status active but not recruiting, primary completion 2024-03-31 actual, estimated completion 2032-03). Randomized, parallel, no masking, treatment. Abstract: primary composite 26.8% versus 45.3% (hazard ratio 0.50); superiority testing in the intention-to-treat population. The registry has not posted results. Findings tabulated: death and stroke percentages only, because the composite and the hospitalization component have 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": "NCT03042104",
      "normalized_value": "NCT03042104",
      "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 early TAVR (balloon-expandable valve) versus clinical surveillance. 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-nct03042104-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2017-07-12",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03042104-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2024-03-31",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct03042104-2026-10-14"
    },
    "completion_date": {
      "date": "2032-03",
      "type": "anticipated",
      "snapshot": "cardio:ctgov-nct03042104-2026-10-14"
    },
    "results_first_posted": null,
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct03042104-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct03042104-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "75 centers in the United States and Canada (abstract).",
      "snapshot": "cardio:pubmed-39466903-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 901,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct03042104-2026-10-14"
      },
      {
        "count": 901,
        "basis": "randomized",
        "unit": "patients",
        "snapshot": "cardio:pubmed-39466903-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:early-tavr-arm-tavr",
        "label": "Early TAVR",
        "intervention": "cardio:sapien-3",
        "description": "Transcatheter aortic valve replacement with the SAPIEN 3 or SAPIEN 3 Ultra valve (registry), balloon-expandable and placed through the femoral artery (abstract)."
      },
      {
        "id": "cardio:early-tavr-arm-cs",
        "label": "Clinical surveillance",
        "intervention": null,
        "description": "Clinical surveillance (registry arm label). 87.0% of this group later had aortic-valve replacement (abstract). No separate intervention record exists for this comparison."
      }
    ],
    "findings": [
      {
        "id": "cardio:f-early-death-tavr",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "cardio:ctx-early-tavr-asymptomatic-severe-as",
        "arm_id": "cardio:early-tavr-arm-tavr",
        "comparator_arm_id": null,
        "claim_id": "cardio:claim-early-tavr-primary",
        "snapshot_id": "cardio:pubmed-39466903-2026-10-14",
        "endpoint_role": "not_specified",
        "effect_measure": "death from any cause (percent of patients)",
        "numeric_value": 8.4,
        "reported_text": "8.4% of patients assigned to TAVR",
        "unit": "percent",
        "denominator": null,
        "denominator_status": null,
        "denominator_basis": "Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.",
        "time_window": "Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "cardio:f-early-death-cs",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "cardio:ctx-early-tavr-asymptomatic-severe-as",
        "arm_id": "cardio:early-tavr-arm-cs",
        "comparator_arm_id": null,
        "claim_id": "cardio:claim-early-tavr-primary",
        "snapshot_id": "cardio:pubmed-39466903-2026-10-14",
        "endpoint_role": "not_specified",
        "effect_measure": "death from any cause (percent of patients)",
        "numeric_value": 9.2,
        "reported_text": "9.2% of patients assigned to clinical surveillance",
        "unit": "percent",
        "denominator": null,
        "denominator_status": null,
        "denominator_basis": "Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.",
        "time_window": "Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "cardio:f-early-stroke-tavr",
        "outcome_id": "core:outcome-stroke",
        "context_id": "cardio:ctx-early-tavr-asymptomatic-severe-as",
        "arm_id": "cardio:early-tavr-arm-tavr",
        "comparator_arm_id": null,
        "claim_id": "cardio:claim-early-tavr-primary",
        "snapshot_id": "cardio:pubmed-39466903-2026-10-14",
        "endpoint_role": "not_specified",
        "effect_measure": "stroke (percent of patients)",
        "numeric_value": 4.2,
        "reported_text": "4.2% of patients assigned to TAVR",
        "unit": "percent",
        "denominator": null,
        "denominator_status": null,
        "denominator_basis": "Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.",
        "time_window": "Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "cardio:f-early-stroke-cs",
        "outcome_id": "core:outcome-stroke",
        "context_id": "cardio:ctx-early-tavr-asymptomatic-severe-as",
        "arm_id": "cardio:early-tavr-arm-cs",
        "comparator_arm_id": null,
        "claim_id": "cardio:claim-early-tavr-primary",
        "snapshot_id": "cardio:pubmed-39466903-2026-10-14",
        "endpoint_role": "not_specified",
        "effect_measure": "stroke (percent of patients)",
        "numeric_value": 6.7,
        "reported_text": "6.7% of patients assigned to clinical surveillance",
        "unit": "percent",
        "denominator": null,
        "denominator_status": null,
        "denominator_basis": "Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.",
        "time_window": "Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      }
    ]
  },
  "content_digest": "344442d0ad3910088116af11b707109ec3f6c712086f6af5afff4ff7529e9b8a",
  "review": {
    "content_digest": "344442d0ad3910088116af11b707109ec3f6c712086f6af5afff4ff7529e9b8a",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Registry arm label: TAVR",
        "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-nct03042104-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.armGroups[0].label"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Registry intervention: SAPIEN 3 / SAPIEN 3 Ultra",
        "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-nct03042104-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Registry condition: severe 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-nct03042104-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[1]"
        },
        "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-nct03042104-2026-10-14",
          "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-nct03042104-2026-10-14",
          "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-nct03042104-2026-10-14",
          "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-39466903-2026-10-14",
          "locator": "Abstract, CONCLUSIONS, sentence 2"
        },
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      }
    ],
    "incoming": []
  },
  "page_path": "studies/early-tavr/",
  "context_path": "api/v1/context/cardio--early-tavr.md"
}