Individualized Approach vs. Fixed Approach

NCT ID: NCT03747263

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-05-07

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Cryoballoon

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Luebeck

OTHER

Sponsor Role: lead

Responsible Party

Christian-H. Heeger, MD

Consultant Rhythmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Heart Center Luebeck, Electrophysiology

Lübeck, , Germany

Countries

Germany

Other Identifiers

18-256

Identifier Type: -

Identifier Source: org_study_id