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OpenTrials
Completed

NCT Number: NCT01711047

Benefit of CFAE Ablation

The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Bournemouth Hospital, Bournemouth, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • persistent atrial fibrillation

Exclusion criteria

  • previous catheter or surgical ablation for atrial fibrillation
  • pregnancy

Treatment and study plan

radiofrequency catheter ablation

Procedure

In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)

Primary outcomes

  1. Single procedural success rate (free from AF off anti-arrhythmic drugs)

    Time frame: 12 MONTHS

Secondary outcomes

  1. Multiple procedure success rate

    Time frame: 12 months after last ablation

  2. Complication rate

    Time frame: 30 days of procedure

  3. Percentage of AF termination

    Time frame: Time 0

    This information will be recorded immediately after the procedure.

  4. recurrence of atrial fibrillation or organised atrial tachycardia

    Time frame: 12 months after the last procedure

  5. Ablation time

    Time frame: Time 0

    This information will be recorded immediately after the procedure.

  6. Procedure time

    Time frame: Time 0

    This information will be recorded immediately after the procedure

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Collaborators

  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Registry information

Official study title

A Study to Investigate the Benefit Of Complex Fractionated Atrial Electrogram (CFAE) Ablation in Addition to Circumferential Pulmonary Vein and Linear Ablations in the Treatment of Persistent Atrial Fibrillation. (BOCA)

Acronym: BOCA

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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