Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy

Study acronym: NIME-CRT
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 2027 → Mar 2028
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Record History

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  1. Primary completion pushed from Mar 2027 to Mar 2028
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 6 of 6 entries
  2. Primary completion date: Mar 2025 to Mar 2027v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis. Cardiac resynchronization therapy (CRT) has been one of the most important advancements in the past two decades for patients with LBBB heart failure. However, 30-40% of patients receiving a CRT do not benefit from it. In this study, the investigators will test a noninvasive device to evaluate acute effect of CRT during implantation and at follow-up CRT controls. In addition, echocardiography will be performed during CRT turned ON and OFF to visualize the changes in intraventricular flow and functional parameters of the heart.
Trial Details
NCT Number NCT05868616
Lead Sponsor Oslo University Hospital
Collaborators: South-Eastern Norway Regional Health Authority, Norwegian Health Association
Conditions
(from sponsor)		 Heart Failure, Pacemaker DDD, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
Related terms Cardiomyopathies, Cardiovascular Diseases, Heart Diseases, Heart Failure
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov