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GreatPFANCT07511166

A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
Track this trial

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Record History

All 9 versions: 5 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Study sites: 0 to 1
  2. Start date: Sep 7, 2026 to Oct 12, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 4 of 19 entries
  3. Start date: Jul 1, 2026 to Sep 7, 2026
    • Primary and study completion dates pushed to Jul 28, 2028
    • Secondary endpoints: 14 to 19
    • Eligibility criteria expanded, about 3 words
    v5
  4. Start date: Mar 31, 2026 to Jul 1, 2026
    • Study completion pushed from Feb 9, 2028 to Mar 28, 2028
    v3
  5. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode
Timeframe: Day 91 to Day 365 post index procedure

Secondary (19)

Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, and AFL
Acute Procedural Success
Acute Reconnection
Repeat Ablation
PV Re-Connection
Show 14 moreShow less
Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Questionnaire Score
Total Procedure Time
Mapping Time
Pulsed Field Ablation (PFA) Application Time
Number of PFA Ablation
Total Fluoroscopy Time
Study Catheter Dwell Time
Ablation Settings Used
Participant Electrophysiology (EP) Lab Time
Richmond Agitation-Sedation Scale Score (RASS)
Pain Visual Analogue Scale (VAS) Score
Participant's Movements During Ablation
Percentage of Participants who Switch from Non-General Anesthesia (GA) to GA
Use of Paralytics and Anesthesia, and Related Drug Details

Arms and interventions

General Anesthesia Group

Participants undergoing ablation for treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF) under general anesthesia will undergo pulsed field ablation (PFA) with Varipulse PFA catheter system including Varipulse catheter and Trupulse generator.

Non-General Anesthesia Group

Participants undergoing ablation for treatment of symptomatic PAF under the non-general anesthesia, including participants with deep sedation and conscious sedation will undergo PFA with the Varipulse PFA catheter system including Varipulse catheter and Trupulse generator.

Sites

1 site in 1 country

  • Zhongshan Hospital Fudan UniversityShanghai, China