Individualized Approach vs. Fixed Approach (INDI-FREEZE)

University of Luebeck

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: Catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03747263

18-256

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Individual Freeze-Catheter ablation

Experimental group

Description:

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.

Treatment:

Procedure: Catheter ablation

Fixed Freeze-Catheter ablation

Active Comparator group

Description:

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.

Treatment:

Procedure: Catheter ablation