Individualized Approach vs. Fixed Approach (INDI-FREEZE)

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

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Luebeck, Germany
    • University Heart Center Luebeck, Electrophysiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual Freeze-Catheter ablation; The individualized "time-to-effect" protocol utilizing the AFA-Pro applies a freeze-cycle until documentation of PVI based on continuous real-time recordings from the Achieve catheter inside the PV. After documentation of PVI the freeze-cycle is prolonged for additional 90 seconds. If no PVI is achieved after 90 seconds or a temperature of -<30° is not reached after 40 seconds the freeze cycle is stopped, the cryoballoon will be repositioned to possibly achieve a better position. Afterwards the freeze-cycle will be restarted. If no real-time PV signal recording can be obtained, a standard freeze-cycle of 180 seconds is applied. No bonus-freeze-cycle is applied in this protocol.	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.; Other Names: Cryoballoon
Active Comparator: Fixed Freeze-Catheter ablation; The fixed-freeze-cycle protocol utilizing the AFA-Pro comprises a fixed freeze-cycle duration of 180 seconds. If PVI is not achieved with the first freeze-cycle, another 180 seconds freeze-cycle will be applied until documented PVI. After PVI no bonus freeze-cycle is applied.	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.; Other Names: Cryoballoon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Procedure duration	Procedure time (minutes)	Intraoperative
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
Radiation exposure of patient and operator	Radiation exposure of patient and operator (Gy/cm2)	Day 0
Radiation exposure duration	Radiation exposure duration (minutes)	Day 0
Periprocedural complications	Periprocedural complications (e.g. phrenic nerve injury, cardiac tamponade, groin injury etc.)	Day 0
Duration of freeze-cycles to achive pulmonary vein isolation	Duration of freeze-cycles to achive pulmonary vein isolation (n=x)	Day 0

Collaborators and Investigators

• Sponsor: University of Luebeck

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 7, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 18-256

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No