Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation

NCT01803438 | Completed Phase 4 DMC

• 1 other identifier: Cryo-FIRST
• Study Type: interventional
• Target: 220
• Locations: 9 countries
• Sites: 19

Brief Summary

The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).

Conditions

Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases

Keywords

paroxysmal Atrial Fibrillation; Cryoablation; Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• Freedom from any atrial arrhythmia recurrence

  The primary endpoint is freedom from any atrial arrhythmia recurrence at 12 months (at least one episode of AF, atrial flutter or atrial tachycardia with a duration \> 30 seconds documented by 7 day Holter ECG or any other printed ECG recording following a blanking period or a dosing optimizing period of 3 months).

  12 months

Secondary Outcomes (9)

• quality of life

  12 months

• Hospital or emergency services accesses

  12 Months

• Freedom from occurrence of AF

  12 months

• Freedom from occurrence of documented left atrial tachycardia and left atrial flutter

  12 months

• Symptomatic palpitations burden

  12 months

Study Arms (2)

AADs

ACTIVE COMPARATOR

AAD therapy based on hospital clinical practice according to ESC Guidelines 2012

Drug: Antiarrhythmic Drugs

Cryoablation procedure

EXPERIMENTAL

electrical pulmonary veins isolation performed with cryoballoon ablation system

Device: cryoballoon ablation system

Interventions

cryoballoon ablation system DEVICE

Cryoablation procedure

Antiarrhythmic Drugs DRUG

AAD therapy based on hospital clinical practice according to ESC Guidelines 2012

AADs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one episode of AF must be documented during the prior year by any kind of ECG recording.
• Subject has structural normal heart with an LVEF ≥ 50%, thickness of the inter-ventricular septum ≤12 mm and left atrium diameters (short axis) \< 46 mm obtained by transthoracic echocardiography.
• Subject has normal ECG parameters (QRS width in the 12 channel surface ECG ≤120 ms, QTc - interval \< 440 ms, PQ - interval ≤ 210 ms; all parameters should be measured at sinus rhythm).
• Subject is at least 18 and not older than 75years old.
• Subject is able and willing to give informed consent.

You may not qualify if:

• Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration \>7 days).
• Subject has documented typical atrial flutter.
• Subject has any history of successful or unsuccessful treatment of AF with class I or III antiarrhythmic or sotalol with the intention to prevent an AF recurrence. Patients pretreated with above AAD at maximum 48 hours with the intention to convert an AF episode are allowed.
• Subject had any previous left atrial ablation.
• Subject had any previous cardiac surgery, e.g. prosthetic valves.
• Subject has permanent pacemaker or defibrillator implant.
• Subject has 2° type II, 3° degree AV-block or left/right bundle branch block pattern.
• Subject has unstable angina pectoris.
• Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
• Subject has symptomatic carotid stenosis.
• Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.
• Subject has any contraindication for oral anticoagulation.
• Subject has any history of previous transient ischemic attack or stroke.
• Subject has known intra-cardiac thrombus formation.
• Subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (19)

nstituto Cardiovascular de Buenos Aires

Buenos Aires, C1428, Argentina

Location

Monash Medical Centre

Melbourne, Australia

Location

Heart Rhythm Management Centre, UZ Brussels - VUB Brussel

Brussels, Belgium

Location

Klinicki bolnicki centar Sestre Milosrdnice

Zagreb, Croatia

Location

Klinicki bolnicki centar Sestre

Zagreb, Croatia

Location

NCHU Amiens

Amiens, France

Location

CHU Grenoble

Grenoble, France

Location

CHU La Pitié

Paris, France

Location

CHU Charles Nicolle

Rouen, France

Location

Kerckhoff - Klinik

Bad Nauheim, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, 60431, Germany

Location

Universitätsklinikum Eppendorf

Hamburg, 20246, Germany

Location

Westpfalz-Klinikum GmbH

Kaiserslautern, 67655, Germany

Location

Klinikum Bogenhausen

Munich, Germany

Location

Maria Cecilia Hospital

Cotignola, 48033, Italy

Location

Ospedale S.S. Giacomo e Cristoforo

Massa, Italy

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Haukeland Hospital

Bergen, Norway

Location

Related Publications (2)

• Andrade JG, Moss JWE, Kuniss M, Sadri H, Wazni O, Sale A, Ismyrloglou E, Chierchia GB, Kaplon R, Mealing S, Bainbridge J, Bromilow T, Lane E, Khaykin Y. The Cost-Effectiveness of First-Line Cryoablation vs First-Line Antiarrhythmic Drugs in Canadian Patients With Paroxysmal Atrial Fibrillation. Can J Cardiol. 2024 Apr;40(4):576-584. doi: 10.1016/j.cjca.2023.11.019. Epub 2023 Nov 23.

  PMID: 38007219 DERIVED

• Pavlovic N, Chierchia GB, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Dekker L, Scazzuso F, Packer DL, de Asmundis C, Pitschner HF, Piazza FD, Kaplon RE, Kuniss M; Cryo-FIRST Investigators. Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms. Am Heart J. 2021 Dec;242:103-114. doi: 10.1016/j.ahj.2021.08.007. Epub 2021 Sep 8.

  PMID: 34508694 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Malte Kuniss, MD

  Kerckhoff - Klinik, Bad Nauheim, Germany

  PRINCIPAL INVESTIGATOR

• GianBattista Chierchia, MD

  Heart Rhythm Management Centre, UZ Brussels - VUB Brussel, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 4, 2013
• Study Start: June 1, 2014
• Primary Completion: October 16, 2019
• Study Completion: January 20, 2020
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

BE (1); DE (5); IT (2); CR (2); AR (1); FR (4); AU (1); NO (1); NL (2)