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New treatment option for Scar-related Atrial Tachycardia
Official title A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
ClinicalTrials.gov ID: NCT07116525
What this study is testing
- What it's testing
- The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with and candidate for clinically indicated catheter mapping and ablation procedure for the management of ventricular tachycardia...
- At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation)...
- Age 18 years or older
- Signed Patient Informed Consent Form (ICF)
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You likely can't join if
- 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)
See the full eligibility criteria
- Diagnosed with and candidate for clinically indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation...
- At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop...
- Age 18 years or older
- Signed Patient Informed Consent Form (ICF)
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- 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)
- Myocardial infarction within the past 2 months (60 days)
- Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months (365 days)
- Uncontrolled heart failure or New York heart association (NYHA) function class IV
- Implanted with a pacemaker or intracardiac cardiac defibrillator or appendage closure device within the past 6 weeks (42 days)
- Patients with known untreatable allergy to contrast media
- Active illness or active systemic infection or sepsis
- Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior
- Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention [PCI])
- Atrial septal closure within the past 6 weeks (42 days)
- Presence of a condition that precludes vascular access
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
- Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
- Concurrent enrollment in an investigational study evaluating another device or drug
The study team makes the final eligibility decision.
Where it's taking place
- Bruges, Belgium
- Hasselt, Belgium
- Nîmes, France
- Pessac, France
- Rennes, France
- Vilnius, Lithuania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bruges, Belgium; Hasselt, Belgium; Nîmes, France; Pessac, France; Rennes, France; Vilnius, Lithuania. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.