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Trial · NCT06973902

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNew York Heart Association class variationFrom enrollment to the end of follow-up, 12 months
The proportion of subjects with clinical response to CCM therapy at 12 months, defined as a reduction of at least 1 class of the New York Heart Association Classification of the functional status of the heart (minimum value I, better outcome, and maximum value IV, worse outcome)
SecondaryHospitalizationsFrom enrollment to the end of follow-up, 12 months
Change in the number of hospitalizations, visits to the Emergency Department, or access to day hospital facilities for more than 4 hours (e.g., by intravenous infusion of cardiac inotropic drugs) compared to the year before the study.
SecondaryMinnesota LIVING WITH HEART FAILURE Questionnaire score variationFrom enrollment to the end of follow-up, 12 monthsChange in the quality-of-life score estimated with the "Minnesota LIVING WITH HEART FAILURE Questionnaire" MLHFQ (minimum value 0, better outcome, and maximum value 105, worse outcome),
Secondary6MWT variationFrom enrollment to the end of follow-up, 12 monthsChange in walk distance between baseline and end of follow-up in the walk test (6MWT)
SecondaryNT-proBNP variationFrom enrollment to the end of follow-up, 12 monthsChange in NT-proBNP level between baseline and end of follow-up
SecondaryLVESV changeFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects with LVESV decreased by ≥ 15% on echocardiography at end-of-follow-up compared to preimplantation
SecondaryVTI changeFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects with increased integral velocity time (VTI) ≥ 20% between preimplantation and end-of-follow-up echocardiography,
SecondaryLVEF changeFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects with a 20% increase in ejection fraction (LVEF) between preimplantation and end-of-follow-up echocardiography
SecondaryMR changeFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects with progression or, conversely, improvement in Mitral Regurgitation (M.R.; classified as mild, moderate, or severe).
SecondaryCRT implantFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects who, during follow-up, will be evolved to cardiac resynchronization system (CRT) implantation
SecondaryLVAD implantFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects who, during follow-up, will be evolved to left ventricular assist device (LVAD) implantation,
SecondaryCardiac TransplantFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects who will have received a cardiac transplant during follow-up
SecondaryHF deathFrom enrollment to the end of follow-up, 12 monthsThe proportion of subjects who will die from H.F. during follow-up
SecondaryAEFrom enrollment to the end of follow-up, 12 monthsRate of all procedure-related adverse events.
SecondaryRe-OperationFrom enrollment to the end of follow-up, 12 monthsRate of re-operations (lead revision/replacement/infection)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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GET https://conductscience.org/api/trials/v1/NCT06973902/registered