Symptomatic Paroxysmal Atrial Fibrillation (PAF) Clinical Trial
Official title:
A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the PVs With a Cryoballoon Catheter vs a Radiofrequency Ablation With a ThermoCool Catheter in Patients With PAF
| NCT number | NCT01490814 |
| Other study ID # | FI-123 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2011 |
| Est. completion date | January 2016 |
| Verified date | March 2018 |
| Source | Medtronic Atrial Fibrillation Solutions |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
| Status | Completed |
| Enrollment | 769 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Symptomatic PAF with at least two episodes and at least one episode documented (30 seconds episode length, documented by ECG within last 12 months). - Documented treatment failure for effectiveness of at least one anti-arrhythmic drug(AAD Type I or III, including ß-blocker and AAD intolerance). - = 18 and = 75 years of age. - Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol. - Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial. Exclusion Criteria: General exclusion criteria - Any disease that limits life expectancy to less than one year. - Participation in another clinical trial (of a drug, device or biologic), either within the past two months or ongoing. - Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intrauterine device (IUD)] or sterile women can be randomized. - Breastfeeding women. - Substance misuse. - Active systemic infection. - Cryoglobulinaemia. - Previous participation in this clinical trial. - Employment by the sponsor or by the department of any of the investigators. - Close relatives of any of the investigators. Exclusion criteria related to a cardiac condition - Patients with prosthetic valves. - Any previous LA ablation or surgery. - Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment. - Unstable angina pectoris. - Myocardial infarction within three months prior to enrollment. - Symptomatic carotid stenosis. - Chronic obstructive pulmonary disease with detected pulmonary hypertension. - Any condition contraindicating chronic anticoagulation. - Stroke or transient ischemic attack within six months prior to enrollment. - Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale. - New York Heart Association (NYHA) class III or IV congestive heart failure. - EF < 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history). - Anteroposterior LA diameter > 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment). - LA thrombus (TEE diagnostic performed on admission). - Intracardiac thrombus. - PV diameter > 26 mm in right sided PVs. - Mitral prosthesis. - Hypertrophic cardiomyopathy (see Appendix IX) - 2° (Type II) or 3° atrioventricular block. - Brugada syndrome or long QT syndrome. - Arrhythmogenic right ventricular dysplasia. - Sarcoidosis. - PV stent. - Myxoma. Exclusion criteria based on laboratory abnormalities - Thrombocytosis (platelet count > 600,000 / µl), thrombocytopenia (platelet count < 100,000 / µl). - Any untreated or uncontrolled hyperthyroidism or hypothyroidism. - Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min). |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Na Homolce Hospital, Cardiology | Prague | |
| France | Hospital Henri Mondor CHU, Service de Cardiologie | Créteil | |
| France | CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel | Lyon | |
| France | Centre Chirurgical Ambroise Paré | Neuilly Sur Seine | |
| France | La Clinique Pasteur, 45 Avenue de Lombez | Toulouse | |
| Germany | Herz-Zentrum Bad Krozingen | Bad Krozingen | |
| Germany | Klinik für Kardiologie II mit interventioneller Elektrophysiologie | Bad Neustadt/Saale | |
| Germany | Cardioangiologisches Centrum Bethanien - CCB | Frankfurt | |
| Germany | Universitätsklinikum Greifswald Elektrophysiologie | Greifswald | |
| Germany | Asklepios Klinik St. Georg | Hamburg | |
| Germany | Herz-Zentrum-Bodensee Konstanz | Konstanz | |
| Hungary | Semmelweis University of Medicine, Kardiovaskuläres Zentrum | Budapest | |
| Italy | Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan | Milan | |
| Netherlands | Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch | Zwolle | |
| Spain | Hospital Clinic, University of Barcelona | Barcelona | |
| Spain | Arrhythmia Unit Hospital Clinico San Carlos | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn | Malaga | |
| Spain | Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit | Valencia | |
| Switzerland | Universitätsspital Basel, Elektrophysiologie/ Kardiologie | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Atrial Fibrillation Solutions | Medtronic |
Czechia, France, Germany, Hungary, Italy, Netherlands, Spain, Switzerland,
Fürnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck KH. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12. — View Citation
Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Subjects With Recurrence of Atrial Arrhythmias or Prescription of Anti-arrhythmic Drug or Re-ablation After a Blanking Period of Three Months After the Initial Ablation Procedure | Number of subjects reporting a primary efficacy endpoint | 33 months | |
| Primary | Number of Subjects With a Primary Safety Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest. | 33 months | ||
| Secondary | All-cause Death | 33 months | ||
| Secondary | Arrhythmia-related Death | 33 months | ||
| Secondary | Total Procedure Duration | Through the initial ablation procedure | ||
| Secondary | Total Time of Fluoroscopy | Fluoroscopy meter time through the initial ablation procedure | ||
| Secondary | Number of Subjects Reporting a Cardiovascular Hospitalization Over the Duration of the Study. | 33 months | ||
| Secondary | Number of Cardiovascular Hospitalizations | The total number of cardiovascular hospitalizations reported over the duration of the study. | 33 months |