NCT01769287

Brief Summary

The purpose of this study is to check if at 1 year after surgical ablation the electrical impulses that cause atrial fibrillation (AF) are still blocked from being able to get into the heart. Hypothesis Conduction block and ganglionic destruction are required for freedom from AF.

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 all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2013

Enrollment Period

8 months

First QC Date

November 1, 2012

Last Update Submit

September 18, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationElectrophysiological Assessment12 months post-operativelyHigh Intensity Ultrasound

Outcome Measures

Primary Outcomes (1)

  • To document the incidence of 1 year post ablation bidirectional conduction block through the pulmonary venous cinch and mitral lines

    Incidence of conduction block post ablation at 12 months across the pulmonary venous and mitral lines.

    1 year

Study Arms (1)

Surgical operation

The study aims to recruit a total of 20 patients, 10 of whom have AF and 10 who do not.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Secondary care clinic - Patients who have undergone an Epicor HIFU ablation \>12 months ago

You may qualify if:

  • Patients who have undergone an Epicor HIFU ablation \>12 months ago
  • Patients having the ability to fully comply with the study requirements
  • Patients who have given written fully informed consent to participate in the study

You may not qualify if:

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Patients who are unable to give full informed consent for the present sub-study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plymouth Hosptals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Malcolm Dalrymple-Hay, MB BS, PhD

    University Hospital Plymouth NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2012

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 19, 2017

Record last verified: 2013-09

Locations

GB(1)