Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data

NCT01730924 | Completed

• 1 other identifier: 008205 QM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation catheter to deliver targeted burns on the inner surface of the heart. The aim of this approach is to cause electrical isolation of the pulmonary veins. The purpose of this study is to evaluate whether the information which can be derived from the latest catheter technologies - on the degree of contact force between the catheter and the heart - affects the time to perform the procedure, or the outcomes as a result of it. Patients undergoing pulmonary vein isolation will be randomised to having their procedure performed with the contact force information available to the operator, or not available. The time taken to achieve pulmonary vein isolation is the primary end-point of the study.

Conditions

Atrial Fibrillation; Atrial Fibrillation Ablation; Pulmonary Vein Isolation

Keywords

Atrial fibrillation; Contact force; Ablation

Outcome Measures

Primary Outcomes (1)

• Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton

Study Arms (2)

Contact force available

OTHER

Procedure: Pulmonary vein isolation using contact force sensing catheter

Contact force not available

OTHER

Procedure: Pulmonary vein isolation using contact force sensing catheter

Interventions

Pulmonary vein isolation using contact force sensing catheter PROCEDURE

Contact force available; Contact force not available

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years, Symptomatic paroxysmal atrial fibrillation (defined as ECG proven episodes of atrial fibrillation which are self limiting and last less than 7 days on each occasion)

You may not qualify if:

• Inability or unwillingness to receive oral anticoagulation Previous ablation procedure for atrial fibrillation Unwillingness or inability to complete the required follow up arrangements Persistent atrial fibrillation Prior prosthetic mitral valve replacement or severe structural cardiac abnormality Known severe left ventricular systolic function (ejection fraction \<35%) Known hypertrophic or infiltrative cardiomyopathy

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust

London, London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• Ullah W, McLean A, Tayebjee MH, Gupta D, Ginks MR, Haywood GA, O'Neill M, Lambiase PD, Earley MJ, Schilling RJ; UK Multicentre Trials Group**. Randomized trial comparing pulmonary vein isolation using the SmartTouch catheter with or without real-time contact force data. Heart Rhythm. 2016 Sep;13(9):1761-7. doi: 10.1016/j.hrthm.2016.05.011. Epub 2016 May 9.

  PMID: 27173976 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

GB (1)