University Heart Center Luebeck, Electrophysiology
Lübeck, Germany
NCT Number: NCT03747263
The purpose of the current study is to assess differences regarding the acute efficacy, safety, procedural duration, radiation exposure and long-term success of the novel AFA-Pro in combination of an individualized shortened ablation protocol containing a reduced freezing time to the standard approach of a fixed ablation protocol in patients with symptomatic PAF.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lübeck, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electrophysiology studies are performed during conscious sedation using boluses of midazolam and fentanyl and a continuous infusion of propofol. Vital parameters are continuously monitored. One 7F standard diagnostic catheter is positioned inside the coronary sinus (CS) via the femoral vein. One 8,5-F sheath is advanced to the left atrium (LA). After transseptal catheterization, intravenous heparin is administered to target an activated clotting time of ≥300 seconds. PV angiographies are obtained for each PV and PV recordings are registered at baseline in SR. The 8.5F transseptal sheath (TS) is changed over the wire for a 12F steerable TS.
Other names: Cryoballoon
Time frame: Month 12
The primary endpoint of the current study is freedom from documented atrial tachyarrhythmia (>/=30 seconds) documented by ECG 4-12 months after PVI off antiarrhythmic drugs. Atrial tachyarrhythmias comprise AF as well as atrial tachycardia and atrial flutter.
Holter-ECGs as well as 12-lead ECGs will be conducted. Every epsiode of documented atrial tachyarrhythmia (>/=30 seconds)outside the blanking period will count as "recurrence".
Time frame: Day 0
Acute procedure success defined as the ability to confirm electrical isolation of the individual pulmonary vein with a circular mapping catheter (achieve catheter). Acute procedure success will be defined as pulmonary vein isolation of all target pulmonary veins.
Pulmonary vein isolation will be detected by entrance block (absence of a pulmonary vein signal) on the circular mapping catheter.
Time frame: Intraoperative
Procedure time (minutes)
Time frame: Day 0
Number (n=x) of freeze-cycles to achive pulmonary vein isolation. For each PV the number of the freeze-cycles will be counted.
Time frame: Day 0
Radiation exposure of patient and operator (Gy/cm2)
Time frame: Day 0
Radiation exposure duration (minutes)
Time frame: Day 0
Periprocedural complications (e.g. phrenic nerve injury, cardiac tamponade, groin injury etc.)
Time frame: Day 0
Duration of freeze-cycles to achive pulmonary vein isolation (n=x)
University of Luebeck
Other
Individualized Approach vs. Fixed Approach Utilizing the Novel Arctic Front Advanced Pro Cryoballoon for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Observational Trial
Acronym: INDI-FREEZE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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