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
Overview
- Phase
- Not Applicable
- Intervention
- Electrical isolation of pulmonary veins
- Conditions
- Symptomatic Paroxysmal Atrial Fibrillation (PAF)
- Sponsor
- Medtronic Cardiac Ablation Solutions
- Enrollment
- 769
- Locations
- 38
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 19 days ago
Overview
Brief Summary
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.
Detailed Description
The purpose of this randomized clinical trial is to compare the efficacy and safety of isolating the PVs with either the cryoballoon or a RF ablation technique with a ThermoCool catheter, a system which can be regarded as standard for ablation. In total 762 patients with paroxysmal atrial fibrillation has been randomized for either radiofrequency (RF) or cryoballoon. With both techniques, PV isolation will be performed. Primary end point of the trial is the time to first recurrence of atrial arrhythmias or prescription of anti-arrhythmic drugs after a blanking period of three months. Treatment success will be evaluated by using weekly electrocardiography (ECG) monitoring (transtelephonic transmission/Tele-ECG) and using Holter electrocardiograms.
Investigators
Eligibility Criteria
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 β-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.
Arms & Interventions
Radiofrequency ablation
Intervention: Electrical isolation of pulmonary veins
Cryoballoon ablation
Intervention: Electrical isolation of the pulmonary veins
Outcomes
Primary Outcomes
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
Time Frame: 33 months
Number of subjects reporting a primary efficacy endpoint
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.
Time Frame: 33 months
Secondary Outcomes
- Arrhythmia-related Death(33 months)
- Total Procedure Duration(Through the initial ablation procedure)
- Number of Subjects Reporting a Cardiovascular Hospitalization Over the Duration of the Study.(33 months)
- All-cause Death(33 months)
- Total Time of Fluoroscopy(Fluoroscopy meter time through the initial ablation procedure)
- Number of Cardiovascular Hospitalizations(33 months)