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Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI

Study acronym: COME-TAVI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from Montreal Heart Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 2026 to Dec 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 18 words
    • Site details revised at 1 of 10 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Dec 2024 to Dec 2026
    • Enrollment target: 200 to 250
    • Study sites: 1 to 10
    v9
  3. Primary completion date: Dec 2023 to Dec 2024v8
  4. Study completion date: Dec 2024 to Dec 2026v7
  5. Primary completion date: Jan 2022 to Dec 2023
    • Study completion date: Jan 2023 to Dec 2024
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jan 2021 to Jan 2022v5 Show 5 more changesShow less
    • Enrollment target: 134 to 200
    • Study completion date: Jan 2022 to Jan 2023
    • Eligibility criteria shortened, about 12 words
    • Site contact updated
    • Study title expanded, about 3 words
  2. Primary completion date: Jan 2019 to Jan 2021
    • Study completion date: Jan 2020 to Jan 2022
    v4
  3. Eligibility criteria shortened, about 3 words
    • Study description expanded, about 2 words
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).
Trial Details
NCT Number NCT03303612
Lead Sponsor Montreal Heart Institute
Conditions
(from sponsor)		 Left Bundle-Branch Block, Aortic Valve Stenosis
Related terms Aortic Valve Stenosis, Bundle-Branch Block
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov