FIRE AND ICE II Trial Pilot

NCT03706677 | Completed DMC

• 1 other identifier: MDT17037
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 5

Brief Summary

The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).

Conditions

Persistent Atrial Fibrillation; Atrial Arrhythmia

Keywords

Ablation; Cryoballoon; Radiofrequency

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure)

  To demonstrate that Cryo ablation is non-inferior to radiofrequency (RF) ablation with respect to time to clinical treatment failure, defined as recurrence of atrial arrhythmias or intervention for AF (a blanking period of three months will be maintained after the index procedure). The first documented recurrence of an episode of atrial arrhythmia after the blanking period lasting at least 30 seconds will be counted for the primary efficacy objective, as well as any intervention for AF with initiation after the blanking period.

  12 Month

• Safety Objective (freedom from device and procedure related serious adverse events (SAEs))

  To demonstrate that Cryo ablation is non-inferior to RF ablation with respect to freedom from device and procedure related serious adverse events (SAEs). The first device or procedure related serious adverse event with onset after start of the index ablation therapy will be used for the safety objective analysis.

  12 Month

Secondary Outcomes (8)

• Assess acute procedural success (PVI)

  3 Month

• Assess quality of life: EQ-5D-5L

  12 Month and 36 Month

• Evaluate post-procedural interventions for atrial arrhythmias

  12 Month and 36 Month

• Evaluate incidence rate of post-procedure events

  12 Month and 36 Month

• Characterize AF burden seen on Reveal LINQ

  12 Month and 36 Month

Study Arms (2)

CRYO group

ACTIVE COMPARATOR

Within the CRYO arm the ablation will be performed using the Arctic Front Advance Cardiac CryoAblation Catheter, including next generation systems as applicable and approved by Medtronic for the trial. Intervention performed: Cryoballoon ablation; Cryoballoon (Arctic Front Advance Cryoballoon)

Device: Cryoballoon (Arctic Front Advance Cryoballoon)

RF group

ACTIVE COMPARATOR

Within the RF arm the ablation will be performed using a catheter out of the ThermoCool Smarttouch catheter family, including next generation contact force systems as applicable. Intervention performed: Radiofrequency ablation; Radiofrequency Catheter (ThermoCool Smarttouch)

Device: Radiofrequency Catheter (ThermoCool Smarttouch)

Interventions

Cryoballoon (Arctic Front Advance Cryoballoon) DEVICE

Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)

CRYO group

Radiofrequency Catheter (ThermoCool Smarttouch) DEVICE

Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)

RF group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documentation of symptomatic persistent AF (following the European Society of Cardiology (ESC) guideline 2016) defined as: Persistent AF - AF that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more
• Date of first diagnosis of persistent AF within the last 12 months preceding the date of screening
• Documented treatment failure or intolerance of at least one Class I or Class III antiarrhythmic drug

You may not qualify if:

• Known pre-existing hemi-diaphragmatic paralysis
• Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
• History of right atrial flutter, not ablated prior to enrollment
• Any cardiac surgery, myocardial infarction, percutaneous coronary intervention or coronary artery stenting which occurred within the 3 months before the eligibility assessment
• Unstable angina pectoris
• Primary pulmonary hypertension
• Any condition contraindicating chronic anticoagulation
• Any cerebral ischemic event (stroke or transient ischemic attack \[TIA\]) which occurred within the 6 months before the consent date
• Presence of any cardiac prosthetic valves
• Long-standing persistent AF lasting for ≥ 1 year (even when it is decided to adopt a rhythm control strategy)
• New York Health Association (NYHA) class III or IV heart failure and/or documented left ventricular ejection fraction (LVEF) \< 40% measured by acceptable cardiac testing (e.g. TTE)
• Acute cardiac condition, including endocarditis, pericarditis or pericardial effusion
• Presence or likely implant of a permanent pacemaker, biventricular pacemaker or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• genae associates (CRO), Antwerp, Belgium: collaborator
• King's College London: collaborator
• Deutsches Herzzentrum Muenchen: collaborator

Study Sites (5)

Clinique Pasteur Toulouse

Toulouse, Cedex 3, 31076, France

Location

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Cardioangiologisches Centrum Bethanien CCB

Frankfurt am Main, 60431, Germany

Location

Asklepios St. Georg

Hamburg, 20099, Germany

Location

Universitätsklinikum Schleswig-Holstein / Campus Lübeck

Lübeck, 23538, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Karl-Heinz Kuck, Prof. Dr.

  Asklepios St. Georg, Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blinded; participants will be blinded to the treatment group. Investigators will be blinded on study specific diagnostics used in the trial; Endpoint Review Committee will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization 1:1 between Cryoballoon ablation and Radiofrequency ablation

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: October 16, 2018
• Study Start: April 5, 2019
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (1); DE (4)