Individualized Approach vs. Fixed Approach

NCT03747263 | Completed

• 1 other identifier: 18-256
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Acute procedure success

  Day 0

• Procedure duration

  Intraoperative

• Number of freeze-cycles to achive pulmonary vein isolation.

  Day 0

• Radiation exposure of patient and operator

  Day 0

• Radiation exposure duration

  Day 0

Study Arms (2)

Individual Freeze-Catheter ablation

EXPERIMENTAL

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

Fixed Freeze-Catheter ablation

ACTIVE COMPARATOR

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

Interventions

Catheter ablation 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.

Also known as: Cryoballoon

Fixed Freeze-Catheter ablation; Individual Freeze-Catheter ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

University Heart Center Luebeck, Electrophysiology

Lübeck, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Rhythmology

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 20, 2018
• Study Start: December 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 7, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

DE (1)