Trial Outcomes & Findings for European Carto® XP REgistry for Validating Specialized CFAE SOftware (NCT NCT00812916)

Results Overview

Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion

Recruitment status

COMPLETED

Target enrollment

206 participants

Primary outcome timeframe

End of procedure

Results posted on

2016-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Number of Patients Radiofrequency (RF) Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Overall Study STARTED	206
Overall Study Data Available	205
Overall Study CFAE - Guided Ablation	203
Overall Study COMPLETED	203
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

European Carto® XP REgistry for Validating Specialized CFAE SOftware

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiofrequency (RF) Ablation n=206 Participants RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Age, Customized Not Collected	206 participants n=5 Participants
Sex/Gender, Customized Not Collected	206 participants n=5 Participants

PRIMARY outcome

Timeframe: End of procedure

Population: Patients with CFAE-guided RF catheter ablation

Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion

Outcome measures

Outcome measures
Measure	Radiofrequency (RF) Ablation n=203 Participants RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Acute Success	48.8 percentage achieving success Interval 41.7 to 55.9

SECONDARY outcome

Timeframe: Procedural

Population: Safety population with ablation time reported

Total time of ablation with exception of 10 outliers with \>180 minutes of total ablation time reported

Outcome measures

Outcome measures
Measure	Radiofrequency (RF) Ablation n=188 Participants RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Total Ablation Time	61.4 minutes Standard Deviation 42.0

SECONDARY outcome

Timeframe: Procedural

Population: Safety population with mapping time reported

Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of \>120 minutes

Outcome measures

Outcome measures
Measure	Radiofrequency (RF) Ablation n=193 Participants RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time	27.7 minutes Standard Deviation 15.4

SECONDARY outcome

Timeframe: Procedural

Population: Safety population with RF data reported

Total duration of all radiofrequency applications with exception of 12 outliers recording \>150 minutes.

Outcome measures

Outcome measures
Measure	Radiofrequency (RF) Ablation n=173 Participants RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Total Radiofrequency (RF) Duration	76.2 minutes Standard Deviation 24.8

SECONDARY outcome

Timeframe: Procedural

Population: Safety population with fluoroscopy time reported

Mean total fluoroscopy time

Outcome measures

Outcome measures
Measure	Radiofrequency (RF) Ablation n=192 Participants RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Total Fluoroscopy Time	43.3 minutes Standard Deviation 28.6

SECONDARY outcome

Timeframe: Procedural

Population: Safety population with non-outlier endpoint reported

Does not include 2 outliers with \>300 CFAE discrete points. Based on the user-defined definition of a CFAE complex, the system identifies the number of intervals between adjacent CFAE complexes and the cycle length of these intervals. This makes it possible to estimate the number of CFAE complexes within certain amplitude and duration values. A CFAE complex is defined by the system based on the intervals between the peaks. Therefore, clinically, the CFAE software includes an algorithm that enables detection of CFAE complexes. The automatic detection and distribution of CFAE signals is taking place during a 2.5 second intra-cardiac ECG recording. When the CFAE areas are completely eliminated, but the arrhythmia continues as organized atrial flutter or atrial tachycardia, the atrial tachy-arrhythmias may be mapped and ablated upon discretion of the investigator. Analyses occur post-procedure.

Outcome measures

Outcome measures
Measure	Radiofrequency (RF) Ablation n=193 Participants RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points	33.5 points Standard Deviation 43.1

Adverse Events

Radiofrequency (RF) Ablation

Serious events: 13 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiofrequency (RF) Ablation n=205 participants at risk RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Cardiac disorders Tamponade	0.49% 1/205 • Peri-procedural, up to duration of study Procedure and/or device related
Injury, poisoning and procedural complications Sheath retained in femoral vein	0.49% 1/205 • Peri-procedural, up to duration of study Procedure and/or device related
Cardiac disorders Pericardial effusion	2.9% 6/205 • Peri-procedural, up to duration of study Procedure and/or device related
Cardiac disorders Epicardial effusion	0.49% 1/205 • Peri-procedural, up to duration of study Procedure and/or device related
Injury, poisoning and procedural complications Hematoma	0.98% 2/205 • Peri-procedural, up to duration of study Procedure and/or device related
Injury, poisoning and procedural complications Phrenic nerve injury	0.49% 1/205 • Peri-procedural, up to duration of study Procedure and/or device related
Respiratory, thoracic and mediastinal disorders Pleural tamponade	0.49% 1/205 • Peri-procedural, up to duration of study Procedure and/or device related

Other adverse events

Other adverse events
Measure	Radiofrequency (RF) Ablation n=205 participants at risk RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
Cardiac disorders Pericardial effusion	1.5% 3/205 • Peri-procedural, up to duration of study Procedure and/or device related

Additional Information

Nathalie Macours

Biosense Webster, EMEA

Phone: +32 2 7463076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
Publication restrictions are in place

Restriction type: OTHER