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

NCT03003975 | Completed

• 1 other identifier: SD-CRYO-AF
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation

Keywords

Ablation; Cryoballoon; Achieve

Outcome Measures

Primary Outcomes (1)

• Frequency of acute pulmonary vein isolation after first ablation.

  Frequency of complete pulmonary vein isolation after first pass of ablation as per protocol

  Acute during ablation procedure

Secondary Outcomes (19)

• Procedure time

  During ablation procedure

• Fluoroscopy exposure

  During ablation procedure

• Freedom from atrial fibrillation

  Evaluated after 12 months

• Adverse/Serious Adverse events

  Evaluated after 12 months

• Quality of Life after ablation

  Evaluated after 12 months

Study Arms (2)

PVI by single cryoballoon application

ACTIVE COMPARATOR

A single cryoballoon application for pulmonary vein isolation will be guided by a Multipolar Recording Catheter (Achieve Mapping Catheter), passed through the inner lumen of the cryoablation catheter. A single application of 4 minutes will be used per vein guided by recording of loss of electrograms and by a defined drop of temperature within 2 minutes application. If a stable position with adequate occlusion of the vein the Achieve catheter should be located proximally for evaluation of entrance block during application, but can be advanced deeper for stability and then retracted to the ostium to evaluate vein isolation (entrance block). If the vein then is isolated after a single application, the operator can move on to the next vein.

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

PVI by 2 cryo applications

ACTIVE COMPARATOR

Cryoballoon ablation with a conventional guidewire passed through the inner lumen of the catheter for stability will be used. Ablation will be performed with 2 consecutive applications for 4 minutes each in each vein guided by degree of occlusion and temperature drop at the discretion of the physician.

Device: PVI by 2 routine cryoballoon applications

Interventions

PVI by single cryoballoon application guided by Achieve Mapping Catheter DEVICE

Pulmonary vein isolation by single cryoballoon application guided by recorded electrogram signals from an internal Mapping Catheter and by temperature drop if mapping of signals is not possible (temperature cutoff \< or = -40 degrees C)

Also known as: Arctic Front™ Advance Cardiac CryoAblation Catheter, Achieve Mapping Catheter

PVI by single cryoballoon application

PVI by 2 routine cryoballoon applications DEVICE

Pulmonary vein isolation by 2 cryoballoon applications guided by degree of occlusion and by temperature drop according to discretion of physician

Also known as: Arctic Front™ Advance Cardiac CryoAblation Catheter

PVI by 2 cryo applications

Eligibility Criteria

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

You may qualify if:

• Patients with paroxysmal or persistent AF verified by ECG
• Patients with symptoms corresponding to at least Europe Heart Rhythm Association (EHRA) score 2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Department of Cardiology, University Hospital in Uppsala

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Carina Blomström Lundqvist, Professor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 28, 2016
• Study Start: November 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)