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OpenTrials
Completed

NCT Number: NCT03747263

Individualized Approach vs. Fixed Approach

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Heart Center Luebeck, Electrophysiology

Lübeck, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Cryoballoon

Primary outcomes

  1. Freedom from documented atrial tachyarrhythmia (every documented episode of atrial tachyarrhythmia lasting >/=30 seconds will be count as recurrence.

    Time frame: Month 12

    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".

Secondary outcomes

  1. Acute procedure success

    Time frame: Day 0

    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.

  2. Procedure duration

    Time frame: Intraoperative

    Procedure time (minutes)

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

    Time frame: Day 0

    Number (n=x) of freeze-cycles to achive pulmonary vein isolation. For each PV the number of the freeze-cycles will be counted.

  4. Radiation exposure of patient and operator

    Time frame: Day 0

    Radiation exposure of patient and operator (Gy/cm2)

  5. Radiation exposure duration

    Time frame: Day 0

    Radiation exposure duration (minutes)

  6. Periprocedural complications

    Time frame: Day 0

    Periprocedural complications (e.g. phrenic nerve injury, cardiac tamponade, groin injury etc.)

  7. Duration of freeze-cycles to achive pulmonary vein isolation

    Time frame: Day 0

    Duration of freeze-cycles to achive pulmonary vein isolation (n=x)

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study 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

Acronym: INDI-FREEZE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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