Non-fluoroscopy Ablation of AF/AT

NCT03750435 | Unknown

• 1 other identifier: BMRBH01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

AF - Atrial Fibrillation; Atrial Tachycardia

Outcome Measures

Primary Outcomes (2)

• Safety of the zero AF procedure

  Absence of acute adverse events due to the use of non-fluoroscopic AF ablation • Evidence of chronic adverse events due to the use of non-fluoroscopic catheter ablation during the 6 months F/U period

  6 months

• Feasibility and efficacy

  Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up

  6 months

Secondary Outcomes (1)

• Recurrences

  6 months

Study Arms (1)

Ablation for AF or left-sided AT

EXPERIMENTAL

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.

Procedure: AF ablation or left-sided AT ablation

Interventions

AF ablation or left-sided AT ablation 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.

Ablation for AF or left-sided AT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Baylis Medical Company: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Sabine Ernst, MD

  Royal Brompton and Harefield NHS

  PRINCIPAL INVESTIGATOR

• Sabine Ernst, MD

  Royal Brompton and Harefield NHS

  STUDY DIRECTOR

Central Study Contacts

Sabine Ernst, MD

CONTACT

02073518612; s.ernst@rbht.nhs.uk

Jenny Rivers

CONTACT

020 7352 8121; j.rivers@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective single arm

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: October 8, 2018
• Primary Completion: April 1, 2019
• Study Completion: October 8, 2019
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)