Pulmonary Vein Isolation Guided by Ablation Index (Ablation Index Registry Study)

NCT03277976 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 490

Last updated 2024-03-05

No results posted yet for this study

Summary

This is a prospective, multi-center, research study designed to evaluate the acute achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool SmartTouch SF (STSF) catheter using the Ablation Index Module.

Conditions

Interventions

DEVICE

PVI using ThermoCool® SmartTouch® Catheter

PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index

DEVICE

PVI using ThermoCool® SmartTouch SF® Catheter

PVI using RFA, using ThermoCool® SmartTouch SF® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index

Sponsors & Collaborators

  • Clinica Mediterranea

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2018-09-28
Completion
2019-11-28

Countries

  • Italy

Study Locations

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Entities

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 NCT03277976 on ClinicalTrials.gov