Individualized Approach vs. Fixed Approach

Paroxysmal Atrial Fibrillation Clinical Trial

— INDI-FREEZE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747263
• Other study ID #: 18-256
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 7, 2020

Study information

• Verified date: May 2020
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 7, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• The patient understands the nature of the study, treatment procedure and provides written informed consent

• Symptomatic paroxysmal atrial fibrillation as defined by the current guidelines

• Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements

• Expected to remain available (geographically stable) for at least 12 months after enrollment

Exclusion Criteria:

• Atrial fibrillation secondary to a reversible cause or of non-cardiac origin

• Previous AF ablation procedure

• Longstanding persistent AF

• Documented left atrial thrombus on imaging (e.g., transesophageal echocardiogram, angiogram)

• NYHA functional Class IV heart failure

• Unstable angina

• Left ventricular ejection fraction < 30%

• Valvular disease requiring interventional treatment

• Cardiac surgery within 3 months prior to enrolment

• Left atrial size > 55 mm as measured in the parasternal antero-posterior view

• Uncontrolled bleeding, diathesis, coagulopathy or pro-coagulant state

• Active systemic infection or sepsis

• Other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
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.

Locations

Country	Name	City	State
Germany	University Heart Center Luebeck, Electrophysiology	Luebeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from documented atrial tachyarrhythmia (every documented episode of atrial tachyarrhythmia lasting >/=30 seconds will be count as recurrence.	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".	Month 12
Secondary	Acute procedure success	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.	Day 0
Secondary	Procedure duration	Procedure time (minutes)	Intraoperative
Secondary	Number of freeze-cycles to achive pulmonary vein isolation.	Number (n=x) of freeze-cycles to achive pulmonary vein isolation. For each PV the number of the freeze-cycles will be counted.	Day 0
Secondary	Radiation exposure of patient and operator	Radiation exposure of patient and operator (Gy/cm2)	Day 0
Secondary	Radiation exposure duration	Radiation exposure duration (minutes)	Day 0
Secondary	Periprocedural complications	Periprocedural complications (e.g. phrenic nerve injury, cardiac tamponade, groin injury etc.)	Day 0
Secondary	Duration of freeze-cycles to achive pulmonary vein isolation	Duration of freeze-cycles to achive pulmonary vein isolation (n=x)	Day 0