Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias

Study acronym: REAL Registry
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Trial sites expanded: 70 → 75 locations
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Publications: details revised at 11 of 11 entries
  2. Primary and study completion dates: Dec 31, 2027 to Dec 31, 2028v21 Show 7 more changesShow less
    • Enrollment target: 15000 to 20000
    • Study sites: 66 to 70
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 57 words
    • Study arms: 1 to 2
    • Study title shortened, about 4 words
  3. Study sites: 65 to 66v20
  4. Study sites: 51 to 65v19
  5. Re-verified, no change to tracked fieldsv18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 49 to 51
    • Publications: 5 to 11
    v17
  2. Study sites: 47 to 49v16
  3. Study sites: 44 to 47v15
  4. Study sites: 40 to 44v14
  5. Enrollment target: 8000 to 15000
    • Primary and study completion dates: Dec 31, 2024 to Dec 31, 2027
    • Study sites: 36 to 40
    v13
  6. Study sites: 29 to 36v12
  7. Study sites: 25 to 29v11
  8. Primary completion date: Mar 30, 2024 to Dec 31, 2024
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 22 to 25
    v10
  9. Enrollment target: 4000 to 8000
    • Primary completion date: Jun 30, 2022 to Mar 30, 2024
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    v9
  10. Primary endpoints: 2 to 3
    • Study sites: 15 to 22
    • Secondary endpoints: 10 to 7
    v8
  11. Study sites: 13 to 15v7
  12. Lead sponsor: Jose Osorio to Heart Rhythm Clinical and Research Solutions, LLCv6 Show 5 more changesShow less
    • Interventions: Catheter ablation with novel radiofrequency technologies (Device) to Catheter ablation (Device)
    • Eligibility criteria shortened, about 64 words
    • Secondary endpoints: 15 to 10
    • Study description shortened, about 281 words
    • Study title expanded, about 2 words
  13. Study sites: 9 to 13v5
  14. Study sites: 5 to 9v4
  15. Study sites: 3 to 5v3
  16. Study sites: 1 to 3v2
  1. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA. The Registry will utilize real world clinical data obtained from the use of commercially available CARTO™ technologies under the authority of a health care practitioner within a legitimate practitioner-subject relationship. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with novel technologies for arrhythmia patients.
Trial Details
NCT Number NCT04088071
Lead Sponsor Heart Rhythm Clinical and Research Solutions, LLC
Collaborators: Biosense Webster, Inc.
Conditions
(from sponsor)		 Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Ventricular Arrhythmia
Related terms Atrial Fibrillation
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov