Non-fluoroscopy Ablation of AF/AT

NCT ID: NCT03750435

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2019-10-08

Brief Summary

Atrial fibrillation is the most common arrhythmia but can be treated by a catheter procedure where specialized wires (so-called catheters) are inserted in the left upper heart chamber. This requires crossing the wall between the right and left atrium with a long needle (a so-called transseptal puncture or TSP). This is typically done using x-ray guidance or echo to check if the needle is in the right position. The investigators developed a method to do the TSP without x-rays using a specialized needle that can be also shown as a little icon on the 3D electroanatomical mapping system (CARTO).3D mapping systems are routinely used to track the location of the catheters in cath labs worldwide, but the position of the needle was not tracked yet. The investigators seek to demonstrate that these procedures can be carried out safely, successfully and in a reproducible fashion without any radiation by taking advantage of "faking" the isolated tip of the needle as a catheter on the 3D mapping system. The results will be compared with historic procedures done by the same operator in the years 2012-2017.

Detailed Description

The hypothesis is that patients who undergo one or more TSP(s) for atrial fibrillation or left atrial tachycardia can be studied without the use of fluoroscopy which should result in a low or ZERO overall radiation exposure for the entire ablation procedure. The investigators will assess the feasibility, safety and efficacy of this new approach.

The patient will be admitted in hospital as for a standard procedure and discharged the next day. Before admission, the patient undergoes a CMR/CT scan (routine in our centre). To avoid total radiation CMR would be preferred, if possible.

The technique of the TSP and the use of the RF needle is commonly used worldwide. The ability to visualize the needle tip on the 3D electroanatomical mapping system facilitates the procedure. The additional visualization by TOE helps to assure that the fossa ovalis has been correctly identified.

After the TSP, the ablation procedure itself will be carried out as conventionally performed using the catheter visualization on the 3D mapping system.

An ECG and an echocardiogram are performed before discharge (as standard care).

At 3 months the patient comes for the first visit and has an ECG, a Holter and symptom questionnaire.

At 6 months, the patient has second visit which includes an ECG, a symptom questionnaire, a Holter and an echocardiogram.

If recurrences of any arrhythmia occur, the patient can be scheduled for a second ablation procedure without any restrictions.

Conditions

AF - Atrial Fibrillation; Atrial Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ablation for AF or left-sided AT

The patient will be admitted in hospital as for a standard ablation procedure and discharged the next day. The procedure will be carried out without using fluoroscopy and relying on the visualization of the electroanatomical mapping system.

Group Type: EXPERIMENTAL

AF ablation or left-sided AT ablation

Intervention Type: PROCEDURE

According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.

Interventions

AF ablation or left-sided AT ablation

According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Any type of atrial fibrillation or left atrial tachycardia

• Able to give written informed consent
• Age >18 years old and ≤ 80 years
• Fulfill established clinical criteria for catheter ablation of atrial fibrillation (1)
• No evidence of significant structural heart disease or congenital heart disease

Exclusion Criteria

Intolerance or unwillingness to oral anticoagulation with Warfarin

• Bleeding disorder
• Contraindication to CT scan
• Presence of intracardiac thrombus
• Vascular disorder preventing access to femoral veins
• Cardiac congenital abnormality
• Severe, life threatening non-cardiac disease
• Active malignant disease and recent (<5 years) malignant disease
• Presence of ASD or PFO closure device
• Unable or unwilling to comply with F/U requirements
• Renal impairment
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylis Medical Company

INDUSTRY

Sponsor Role: collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Ernst, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Harefield NHS

Sabine Ernst, MD

Role: STUDY_DIRECTOR

Royal Brompton and Harefield NHS

Locations

Royal Brompton and Harefield NHS Foundation Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sabine Ernst, MD

Role: CONTACT

s.ernst@rbht.nhs.uk

02073518612

Jenny Rivers

Role: CONTACT

j.rivers@rbht.nhs.uk

020 7352 8121

Facility Contacts

Jenny Rivers

Role: primary

j.rivers@rbht.nhs.uk

020 7352 8121

Other Identifiers

BMRBH01

Identifier Type: -

Identifier Source: org_study_id