Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03003975
• Date of registration: 09/12/2016
• Prospective Registration: No
• Primary sponsor: Uppsala University Hospital
• Public title: Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation SD-CRYO-AF
• Scientific title: Efficacy of Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation (SD-Cryo-AF): A Randomized Study
• Date of first enrolment: November 2014
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03003975
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Carina Blomström Lundqvist, Professor
• Affiliation: Uppsala University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with paroxysmal or persistent AF verified by ECG

- Patients with symptoms corresponding to at least Europe Heart Rhythm Association
(EHRA) score 2.

Exclusion Criteria:

- Sinus rhythm cannot be maintained for at least one hour after an electrical
cardioversion.

- Congestive heart failure with New York Heart Association (NYHA) class 3 or more.

- Left ventricular ejection fraction < 35% not secondary to AF with inadequate rate
control, according to the judgement of the investigator.

- Left atrial diameter = 55 mm judged by transthoracic echocardiography.

- Prior AF ablation procedure.

- Longstanding persistent AF

- AF secondary to a transient or correctable abnormality including electrolyte
imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled
thyroid disease as well as AF triggered by other uniform supraventricular tachycardia.

- Contraindication to treatment with anticoagulants.

- Significant valvular disease or planned cardiac intervention.

- Hypertrophic cardiomyopathy.

- Recent cardiac disease states within the last 6 months; unstable angina, acute
myocardial infarction, revascularisation procedures, valve disease

- Implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT)
device.

- Dual chamber- and single chamber-pacemaker when the patient is pacemaker dependent on
ventricular level

- Patients with contraindications for transseptal catheterization or appropriate
vascular access is precluded.

- Renal failure requiring dialysis or abnormalities of liver function tests.

- Participant in investigational clinical or device trial.

- Unwilling or unable to give informed consent or inaccessible for follow-up and
psychological problem that might limit compliance.

- Active abuse of alcohol or other substance which may be causative of AF and/or might
affect compliance.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Device: PVI by 2 routine cryoballoon applications

Device: PVI by single cryoballoon application guided by Achieve Mapping Catheter

Primary Outcome(s)

Frequency of acute pulmonary vein isolation after first ablation. [Time Frame: Acute during ablation procedure]

Secondary Outcome(s)

Maximum troponin I (ng/L) levels after ablation as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Age (years) as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Reduction of symptom severity score after ablation [Time Frame: Evaluated after 12 months]

Adverse/Serious Adverse events [Time Frame: Evaluated after 12 months]

Sex as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Hospitalisation after ablation [Time Frame: Evaluated after 12 months]

Quality of Life after ablation [Time Frame: Evaluated after 12 months]

Procedure time [Time Frame: During ablation procedure]

CHADsVASc score as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Freedom from atrial fibrillation [Time Frame: Evaluated after 12 months]

BMI (kg/m2) as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Fluoroscopy exposure [Time Frame: During ablation procedure]

Left atrial volume (ml/m2) before ablation as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Atrial conduction time as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Nt-proBNP levels before ablation as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Cost of ablation procedure [Time Frame: Evaluated after initial ablation (within 24 h after ablation)]

Left atrial diameter (mm) before ablation as a predictor of clinical success [Time Frame: Evaluated after 12 months]

Quality of life after ablation (measured as EQ5D score) [Time Frame: Evaluated after 12 months]

Reduction of overall symptoms of atrial fibrillation after ablation [Time Frame: Evaluated after 12 months]

Secondary ID(s)

SD-CRYO-AF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors