Brief Summary

Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice of six different devices that he or she can use to treat your atrial fibrillation. It is not known at this point which device is best at treating you, as each device seems to have the same success rate at curing atrial fibrillation. One of the six devices will be selected randomly by card pulled out at the time of enrollment. It is therefore the purpose of this study to compare the devices to each other and to follow up after surgery to determine if any one device is best. This information will be valuable to surgeons and to patients as the treatment for atrial fibrillation develops in the future.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Timeline

Completed

Started Apr 2007

Geographic Reach

1 country

1 active site

Status

withdrawn

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

2.1 years study duration

Study Start

First participant enrolled

April 1, 2007

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2008

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

April 25, 2007

Last Update Submit

August 15, 2018

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationablation device comparisonablation in right atria

Outcome Measures

Primary Outcomes (3)

Freedom from Atrial fibrillation
No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, Brain Natriuretic Peptide (BNP) levels
3 months after surgery
Rhythm at 12 months
No atrial fibrillation noted by standard testing (Spot ECG, history, 24-hour Holter recording, Cardiac MRI or echocardiogram, BNP levels
12 months after surgery
Major Adverse Cardiovascular Events (MACEs) at 1 and 3 months
Recording any major adverse cardiovascular events reported
1 and 3 months post-surgical procedure

Secondary Outcomes (3)

Functional and qualitative improvement in heart failure, ejection fraction, left atrial size, exercise tolerance
6 and 12 months post-surgical procedure
Rhythm at 3, 6 and 9 months
3, 6 and 9 months post-surgical procedure
All other adverse events
From surgical procedure through 12 months follow-up

Study Arms (6)

Dry bipolar radiofrequency (RF) clamp

ACTIVE COMPARATOR

used for ablation during surgical procedure

Device: Dry bipolar radiofrequency (RF) clamp

Unipolar microwave antenna

ACTIVE COMPARATOR

used for ablation during surgical procedure

Device: Unipolar microwave antenna

Unipolar cryothermic probe

ACTIVE COMPARATOR

used for ablation during surgical procedure

Device: Unipolar cryothermic probe

Irrigated unipolar RF antenna

ACTIVE COMPARATOR

used for ablation during surgical procedure

Device: Irrigated unipolar RF antenna

Irrigated bipolar RF clamp

ACTIVE COMPARATOR

used for ablation during surgical procedure

Device: Irrigated bipolar RF clamp

Hi-intensity focused ultrasound wand

ACTIVE COMPARATOR

used for ablation during surgical procedure

Device: Hi-intensity focused ultrasound wand