{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:coapt",
  "owner": "cardio",
  "kind": "study",
  "slug": "coapt",
  "name": "COAPT trial",
  "aliases": [
    "COAPT",
    "Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A trial in 614 people with heart failure and a leaking mitral valve caused by the weak heart muscle, who still had symptoms on maximal medicines. Adding the MitraClip device to medicines led to fewer hospital stays for heart failure and fewer deaths within two years than medicines alone. It was paid for by Abbott, the applicant for the device's US approval, and the registry lists no masking.",
  "summary_technical": "Registry NCT01626079 (Abbott Medical Devices lead sponsor, class industry, status unknown, estimated completion 2024-07 which is out of date). Randomized, parallel, no masking, treatment. The registry count (776) includes a continued access study (COAPT CAS, 162 patients); the paper reports 614 enrolled. Abstract: annualized heart-failure hospitalizations 35.8% versus 67.9% per patient-year (hazard ratio 0.53); death within 24 months 29.1% versus 46.1% (hazard ratio 0.62). Findings tabulated: death only, because the hospitalization end point 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": "NCT01626079",
      "normalized_value": "NCT01626079",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "valvular-and-congenital-disease",
        "heart-failure"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group, open-label trial of transcatheter mitral-valve repair plus medical therapy versus medical therapy alone. The registry records allocation as randomized, intervention model as parallel and masking as none, and adds a continued access group.",
    "drug_phase": "not_applicable",
    "registry_statuses": [
      {
        "status": "UNKNOWN",
        "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2012-08",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2019-03",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
    },
    "completion_date": {
      "date": "2024-07",
      "type": "anticipated",
      "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
    },
    "results_first_posted": {
      "date": "2020-05-06",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "78 sites in the United States and Canada (abstract).",
      "snapshot": "cardio:pubmed-30280640-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 776,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct01626079-2026-10-14"
      },
      {
        "count": 614,
        "basis": "enrolled",
        "unit": "patients",
        "snapshot": "cardio:pubmed-30280640-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:coapt-arm-device",
        "label": "MitraClip plus medical therapy",
        "intervention": "cardio:mitraclip",
        "description": "Percutaneous mitral valve repair using the MitraClip System, with maximal guideline-directed medical therapy (registry and abstract)."
      },
      {
        "id": "cardio:coapt-arm-control",
        "label": "Medical therapy alone",
        "intervention": null,
        "description": "Patients managed non-surgically based on standard hospital clinical practice (registry control group); medical therapy alone (abstract). No separate intervention record exists for this comparison."
      }
    ],
    "findings": [
      {
        "id": "cardio:f-coapt-death-device",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "cardio:ctx-coapt-hf-secondary-mr",
        "arm_id": "cardio:coapt-arm-device",
        "comparator_arm_id": null,
        "claim_id": "cardio:claim-coapt-all-cause-death",
        "snapshot_id": "cardio:pubmed-30280640-2026-10-14",
        "endpoint_role": "not_specified",
        "effect_measure": "death from any cause within 24 months (percent of patients)",
        "numeric_value": 29.1,
        "reported_text": "29.1% of the patients in the device group",
        "unit": "percent",
        "denominator": null,
        "denominator_status": null,
        "denominator_basis": "Percentage of the patients in the group; 302 were randomized to the device group and 312 to the control group (abstract). No event counts are given.",
        "time_window": "Within 24 months of follow-up (abstract)",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "cardio:f-coapt-death-control",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "cardio:ctx-coapt-hf-secondary-mr",
        "arm_id": "cardio:coapt-arm-control",
        "comparator_arm_id": null,
        "claim_id": "cardio:claim-coapt-all-cause-death",
        "snapshot_id": "cardio:pubmed-30280640-2026-10-14",
        "endpoint_role": "not_specified",
        "effect_measure": "death from any cause within 24 months (percent of patients)",
        "numeric_value": 46.1,
        "reported_text": "46.1% of the patients in the control group",
        "unit": "percent",
        "denominator": null,
        "denominator_status": null,
        "denominator_basis": "Percentage of the patients in the group; 302 were randomized to the device group and 312 to the control group (abstract). No event counts are given.",
        "time_window": "Within 24 months of follow-up (abstract)",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "cardio:f-coapt-death-hr",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "cardio:ctx-coapt-hf-secondary-mr",
        "arm_id": "cardio:coapt-arm-device",
        "comparator_arm_id": "cardio:coapt-arm-control",
        "claim_id": "cardio:claim-coapt-all-cause-death",
        "snapshot_id": "cardio:pubmed-30280640-2026-10-14",
        "endpoint_role": "not_specified",
        "effect_measure": "hazard ratio, device versus control",
        "numeric_value": 0.62,
        "reported_text": "hazard ratio 0.62; 95% CI, 0.46 to 0.82; P<0.001",
        "unit": "ratio",
        "denominator": null,
        "denominator_status": "not_applicable",
        "denominator_basis": "Comparison of the two per-arm rows (302 versus 312 randomized)",
        "time_window": "Within 24 months of follow-up (abstract)",
        "estimate_lower": 0.46,
        "estimate_upper": 0.82,
        "interval_method": "95% confidence interval",
        "interval_status": null
      }
    ]
  },
  "content_digest": "184314c157668796d953cc83e577a9f111d87184d7851459d5ad7db1655c286c",
  "review": {
    "content_digest": "184314c157668796d953cc83e577a9f111d87184d7851459d5ad7db1655c286c",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Registry intervention: MitraClip System",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:mitraclip",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct01626079-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Registry condition: mitral regurgitation",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:mitral-regurgitation",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct01626079-2026-10-14",
          "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:abbott",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct01626079-2026-10-14",
          "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-30280640-2026-10-14",
          "locator": "Abstract, CONCLUSIONS, sentence 3"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Studies people with this condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:heart-failure",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct01626079-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[3]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "A listed paper reports outcomes after mitral transcatheter edge-to-edge repair in the trial",
        "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:ctgov-nct01626079-2026-10-14",
          "locator": "protocolSection.referencesModule.references[9].citation"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/coapt/",
  "context_path": "api/v1/context/cardio--coapt.md"
}