Clinical Trials Logo

Clinical Trial Summary

This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).


Clinical Trial Description

This is a prospective, randomized clinical study performed at one centre. The objective is to assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation in patients with atrial fibrillation (AF).

140 subjects with paroxysmal or persistent atrial fibrillation referred for their first AF ablation procedures will be enrolled.

Recruitment, ablation and follow-up will be performed at Dep of Cardiology in Uppsala University Hospital, Uppsala, Sweden.

Study duration is 2 years with 12--months enrolment period and 1 year follow-up per subject.

Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon ablation catheter. Patients will be randomized to a single cryoballoon application guided by a multipolar recording catheter or to a conventional technique with 2 cryoballoon applications. After cryoballoon ablation of all pulmonary veins, PV conduction block will be assessed by a separate circular mapping catheter. Acute procedural success is defined as complete electrical isolation of a pulmonary vein assessed by entrance and exit block, including 20 minutes waiting time. Complications and duration of the procedure will be assessed.

Patients will be followed at three, six and 12 months after the ablation procedure. A 12 lead ECG, a 7 day Holter monitoring, quality of life (EQ5D) and EHRA score, will be performed at baseline, 6 and 12 months. as well as Biomarkers including nTproBNP and troponin I, will be performed at baseline, and at 6 and 12 months (only nTproBNP). Predictive variables for successful outcome/AF recurrence will be analysed.

The frequency of symptomatic recurrence of AF and number of reablations will be compared at 6 and 12 months, and in those requiring a redo ablation procedure the status of PV reconduction will be assessed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03003975
Study type Interventional
Source Uppsala University Hospital
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date March 2017

See also
  Status Clinical Trial Phase
Recruiting NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Active, not recruiting NCT04546763 - Study Watch AF Detection At Home
Recruiting NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A
Completed NCT03313167 - Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
Active, not recruiting NCT04544397 - Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
Completed NCT02923414 - Comparison of High Versus Escalating Shocks in Cardioverting Atrial Fibrillation N/A
Recruiting NCT04590898 - Peri-device Leakage Closure After LAAO
Completed NCT03593486 - Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation N/A
Recruiting NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Terminated NCT04076917 - Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
Active, not recruiting NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Recruiting NCT04037397 - First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3) Phase 3
Recruiting NCT03503812 - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches N/A
Recruiting NCT04170894 - Radiofrequency Ablation of Atrial Fibrillation Under Apnea N/A