RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter for Scar-related Atrial Tachycardia

Q: Is NCT07116525 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07116525?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07116525?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This study wants to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.

Official registry: https://clinicaltrials.gov/study/NCT07116525 · Biosense Webster, Inc. · enrollment listed as 90

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter. The registry lists allocation as na. This study wants to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.

They plan to enroll about 90 people at 5 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)

Interventions: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter

Primary outcome (registry wording): Occurrence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping

Who it is for (from inclusion criteria)

Ages 18 Years to any
Age 18 years or older

Who the registry excludes

Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause
Patients requiring left atrial procedures: left atrial size greater than (\>) 55 millimeter (mm)
Left ventricular ejection fraction(LVEF) less than or equal to (\<=) 25 percentage (%) for participants with ventricular arrhythmia
LVEF \<= 40% for participants with atrial arrhythmia
Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)
History of blood clotting or bleeding abnormalities (example hypercoagulable state)

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

AZ Sint-Jan — Bruges, Belgium (recruiting)
Jessa Ziekenhuis — Hasselt, Belgium (recruiting)
CHU de Bordeaux - Hospital Haut-Leveque — Pessac, France (recruiting)
Chu Rennes Hopital Pontchaillou — Rennes, France (recruiting)
Vilnius University Hospital Santaros Clinics — Vilnius, Lithuania (recruiting)

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FAQ about this NCT record

Is NCT07116525 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07116525?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07116525?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary