Trial Outcomes & Findings for Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs (NCT NCT00477230)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

64 participants

Primary outcome timeframe

One Year

Results posted on

2012-06-27

The study was terminated early by the decision of the Sponsor after 64 participants were enrolled and 25 were treated.

None outside of the protocol.

Participant milestones
Measure	Single Ablation Procedure With Endoscopic Ablation System Single ablation procedure with Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy Medication as prescribed by physician.
Overall Study STARTED	32	32
Overall Study COMPLETED	12	1
Overall Study NOT COMPLETED	20	31

Withdrawal data not reported

Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs

Baseline characteristics by cohort
Measure	Single Ablation Procedure With Endoscopic Ablation System n=32 Participants Single ablation procedure with Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy n=32 Participants Medication as prescribed by physician.	Total n=64 Participants Total of all reporting groups
Age, Customized Less than 18 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Greater than or equal to 18 Years	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Sex/Gender, Customized Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Unknown	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	32 participants n=7 Participants	64 participants n=5 Participants

Timeframe: One Year

Population: Early study termination before one year.

Outcome data not reported

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	Single Ablation Procedure With Endoscopic Ablation System n=32 participants at risk Single ablation procedure with Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy n=32 participants at risk Medication as prescribed by physician.
Cardiac disorders Mechanical Perforation	12.5% 4/32 • After treatment and during up to 1 year follow-up.	0.00% 0/32 • After treatment and during up to 1 year follow-up.
Cardiac disorders Pericarditis	3.1% 1/32 • After treatment and during up to 1 year follow-up.	0.00% 0/32 • After treatment and during up to 1 year follow-up.

Other adverse events
Measure	Single Ablation Procedure With Endoscopic Ablation System n=32 participants at risk Single ablation procedure with Endoscopic Ablation System	Standard Anti-arrhythmic Drug Therapy n=32 participants at risk Medication as prescribed by physician.
Respiratory, thoracic and mediastinal disorders diaphragmatic paralysis	6.2% 2/32 • After treatment and during up to 1 year follow-up.	0.00% 0/32 • After treatment and during up to 1 year follow-up.
Ear and labyrinth disorders chest pain	6.2% 2/32 • After treatment and during up to 1 year follow-up.	0.00% 0/32 • After treatment and during up to 1 year follow-up.
Injury, poisoning and procedural complications Medication Intolerance	0.00% 0/32 • After treatment and during up to 1 year follow-up.	15.6% 5/32 • After treatment and during up to 1 year follow-up.

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