Clinical evaluation of the Gen2 irrigated ablation catheter for the treatment of cardiac arrhythmias

Withdrawn

• Conditions: Atrial fibrillation; 10007521

• Registration Number: NL-OMON31563
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 103

Inclusion Criteria

Be between eighteen and eighty years of age;
Be scheduled for an atrial fibrilation ablation procedure;
Be able to undergo contrast-enhanced MRI imaging;
Have a cardiac CT or MRI scan within a 6 months time window prior to the planned procedure ;
Be willing and able to sign the study specific consent form;
Be willing and able to fulfill study requirements (including study follow-up visits);
Have a negative pregnancy test for females in case of doubt about a possible pregnancy and
Have documented paroxysmal or persistent atrial fibrillation (by electrocardiogram (ECG); trans-telephonic monitor (TTM); Holter monitor or telemetry strip)

Exclusion Criteria

Have evidence of or is currently receiving treatment for infection (local or systemic);
Have evidence of LA thrombus prior to procedure;
Be hypercoaguable (unable to tolerate heparin anticoagulation therapy) during the procedure;
Have history of embolic event(s). (e.g., cerebrovascular accident, pulmonary embolism, transient ischemic attack, etc.);
Have experienced a myocardial infarction <=3 months prior to the study procedure;
Have recent history (<=3 months) of cardiac surgery; including device implants (e.g. pacemaker, implantable cardiac defibrillator, etc.);
Have significant coronary heart disease or heart failure (i.e. unstable angina pectoris and/or uncontrolled congestive heart failure resulting in NYHA Class III or IV) at the time of enrollment, except in cases where the NYHA Class III diagnosis is due to sustained AFL with rapid ventricular response;
Have history of any previous cardiac ablation for atrial fibrillation;
Have prosthetic heart valve or valvular heart disease requiring surgical intervention;
Have a pacemaker or ICD leads in or around the coronary sinus or coronary vasculature;
Be awaiting cardiac transplant or other cardiac surgery within the following 12 months;
Have significant pulmonary disease, or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms;
Have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive EP catherization;
Have any condition for which the subject*s life expectancy is less than 12 months and
Be currently participating in another investigational study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified