New heart procedure tested to control dangerous irregular heartbeat

NCT ID NCT05971693

Completed Disease control Sponsor: Biosense Webster, Inc. Source: ClinicalTrials.gov ↗

Summary

This study tested the safety and effectiveness of a new medical device system (the OMNYPULSE catheter and TRUPULSE generator) for treating a type of irregular heartbeat called paroxysmal atrial fibrillation (PAF). The procedure aims to electrically isolate the problematic heart veins to prevent faulty signals. Researchers enrolled 188 participants with symptomatic PAF to see if the procedure was safe and if it successfully stopped the irregular rhythms for up to a year.

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Contacts and locations

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Locations

AZ Sint-Jan

Bruges, 8000, Belgium
AZORG campus Aalst Moorselbaan

Aalst, 9300, Belgium
Generale Regionale F. Miulli

Acquaviva delle Fonti, 70021, Italy
IKEM

Prague, 140 21, Czechia
Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium
KBC Split

Split, 21000, Croatia
MVZ CCB Frankfurt und Main Taunus GbR

Frankfurt a.M., 60431, Germany
Maastricht UMC

Maastricht, 6229 HX, Netherlands
McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada
Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada
Nemocnice na Homolce

Prague, 150 30 District 5, Czechia
Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania
Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Conditions

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ATRIAL FIBRILLATION