Persistent Atrial Fibrillation Ablation Trial

NCT ID: NCT01891825

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pecutaneous AF ablation

Percutaneous catheter ablation of atrial fibrillation

Group Type ACTIVE_COMPARATOR

Percutaneous AF ablation

Intervention Type PROCEDURE

Percutaneous catheter ablation of atrial fibrillation

Surgical AF ablation

Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

Group Type ACTIVE_COMPARATOR

Surgical AF ablation

Intervention Type PROCEDURE

Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

Interventions

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Surgical AF ablation

Minimally invasive thoracoscopic surgical ablation of atrial fibrillation

Intervention Type PROCEDURE

Percutaneous AF ablation

Percutaneous catheter ablation of atrial fibrillation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic persistent or long-standing AF suitable for AF ablation.
* Age over 18 years old.
* Informed consent to participate in this study.

Exclusion Criteria

* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
* Unable to undergo general anaesthesia for AF ablation.
* Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Previous thoracic surgery.
* Participation in a conflicting study.
* Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
* Pregnancy
* Other cardiac rhythm disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neil Sulke

OTHER

Sponsor Role lead

Responsible Party

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Neil Sulke

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Neil Sulke, DM

Role: PRINCIPAL_INVESTIGATOR

Eastbourne General Hospital

Locations

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Eastbourne General Hospital

Eastbourne, E Sussex, United Kingdom

Site Status

Royal Sussex County Hospital

Brighton, East Sussex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PAAT

Identifier Type: -

Identifier Source: org_study_id

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