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Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation

NCT03729830 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 415

Last updated 2026-01-21

Study results available
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Summary

To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.

Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Boston Scientific Open Irrigated Ablation Catheters

The BSC Open-Irrigated catheters are designed to deliver RF energy to catheter tip electrode for cardiac ablation. The BSC OI catheters incorporate an open-irrigated cooling mechanism through a tip that is partitioned into two chambers. The proximal chamber circulates normal saline (0.9 %) within the tip to cool the proximal electrode and mitigate overheating while the distal chamber allows the fluid to flow through six irrigation holes into the patient's vasculature, thereby cooling the tip/tissue interface.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Oussama Wazni · The Cleveland Clinic

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2024-05-03
Completion
2024-05-03
FDA Device
Yes

Countries

  • United States
  • Germany
  • Japan
  • Monaco
  • South Korea
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729830 on ClinicalTrials.gov