NCT02267889

Brief Summary

This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac camera will guide the GP ablation procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

October 14, 2014

Last Update Submit

February 6, 2018

Conditions

Atrial Fibrillation

Keywords

Ganglionated plexi

Outcome Measures

Primary Outcomes (2)

  • Termination of atrial fibrillation during image guided ablation

    At the time of the ablation procedure.

  • Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.

    12 months post the index ablation procedure.

Secondary Outcomes (4)

  • Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)

    Up to 12 months from the index ablation procedure

  • Freedom from atrial fibrillation on previously failed antiarrhythmic medication

    12 months from the index ablation procedure.

  • Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure.

    12 months from the index ablation procedure.

  • Left atrial transport function

    6 months and 12 months post the index ablation procedure

Study Arms (1)

Image guided GP ablation

EXPERIMENTAL

Use of cardiac nuclear imaging data to guide GP ablation procedures.

Procedure: Image guided GP ablationDevice: D-SPECT dedicated cardiac nuclear camera

Interventions

Image guided GP ablationPROCEDURE

3D imaging data from the D-SPECT system will be used to visualise the GP and guide the location of catheter ablation sites during the electrophysiology procedure.

Also known as: D-SPECT dedicated cardiac nuclear camera
Image guided GP ablation
D-SPECT dedicated cardiac nuclear cameraDEVICE
Image guided GP ablation

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Paroxysmal or early persistent atrial fibrillation with ongoing AF for less than 1 week
  • Able to give written informed consent
  • Age \>18 years old and ≤ 80 years
  • Fulfil established clinical criteria for catheter ablation of atrial fibrillation
  • Normal left ventricular (LV) ejection fraction and no evidence of significant structural heart disease

You may not qualify if:

  • Reversible cause of atrial fibrillation
  • Recent cardiovascular event including transient ischaemic attack (TIA)
  • Intolerance or unwillingness to oral anticoagulation with Warfarin
  • Bleeding disorder
  • Contraindication to computed tomography (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 or recent (\<5 years) malignant disease
  • Presence of atrial septal defect (ASD) or patent foramen ovale (PFO) closure device
  • Unable or unwilling to comply with follow-up requirements
  • Patients on amiodarone until less than 3 months prior to the screening visit
  • Left atrium size \> 5.5 cm on parasternal diameter in transthoracic echocardiography (TTE)
  • Renal impairment
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sabine Ernst, MD

    The Royal Brompton Hospital, London, UK

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 20, 2014

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

GB(1)