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Individualized Approach vs. Fixed Approach (INDI-FREEZE)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Catheter ablation
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Heart Center Luebeck, Electrophysiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individual Freeze-Catheter ablation

Fixed Freeze-Catheter ablation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2018
Last Updated
May 20, 2020
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT03747263
Brief Title
Individualized Approach vs. Fixed Approach
Acronym
INDI-FREEZE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Freeze-Catheter ablation
Arm Type
Experimental
Arm 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.
Arm Title
Fixed Freeze-Catheter ablation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Other Intervention Name(s)
Cryoballoon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freedom from documented atrial tachyarrhythmia (every documented episode of atrial tachyarrhythmia lasting >/=30 seconds will be count as recurrence.
Description
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".
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Acute procedure success
Description
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.
Time Frame
Day 0
Title
Procedure duration
Description
Procedure time (minutes)
Time Frame
Intraoperative
Title
Number of freeze-cycles to achive pulmonary vein isolation.
Description
Number (n=x) of freeze-cycles to achive pulmonary vein isolation. For each PV the number of the freeze-cycles will be counted.
Time Frame
Day 0
Title
Radiation exposure of patient and operator
Description
Radiation exposure of patient and operator (Gy/cm2)
Time Frame
Day 0
Title
Radiation exposure duration
Description
Radiation exposure duration (minutes)
Time Frame
Day 0
Title
Periprocedural complications
Description
Periprocedural complications (e.g. phrenic nerve injury, cardiac tamponade, groin injury etc.)
Time Frame
Day 0
Title
Duration of freeze-cycles to achive pulmonary vein isolation
Description
Duration of freeze-cycles to achive pulmonary vein isolation (n=x)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Heart Center Luebeck, Electrophysiology
City
Luebeck
Country
Germany

12. IPD Sharing Statement

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Individualized Approach vs. Fixed Approach

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