Trial Outcomes & Findings for Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation (NCT NCT02093949)

NCT ID: NCT02093949

Last Updated: 2017-11-06

Results Overview

percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure

• Recruitment status: COMPLETED
• Target enrollment: 152 participants
• Primary outcome timeframe: up to 240 min
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	Substrate Ablation Between September 2013 and July 2014, 105 patients with AF were prospectively enrolled at three centers performing substrate ablation (without pulmonary vein isolation) routinely	Historical Control The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
Overall Study STARTED	105	47
Overall Study COMPLETED	105	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

Baseline characteristics by cohort

Measure	Substrate Ablation n=105 Participants Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.	Historical Control n=47 Participants Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach	Total n=152 Participants Total of all reporting groups
Age, Continuous	63 year STANDARD_DEVIATION 11 • n=5 Participants	58 year STANDARD_DEVIATION 11 • n=7 Participants	61 year STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	35 Participants n=7 Participants	115 Participants n=5 Participants
Paroxysmal AF	24 participants n=5 Participants	9 participants n=7 Participants	33 participants n=5 Participants
Nonparoxysmal AF	81 participants n=5 Participants	38 participants n=7 Participants	119 participants n=5 Participants
Structural heart disease	38 participants n=5 Participants	14 participants n=7 Participants	52 participants n=5 Participants
Hypertension	48 participants n=5 Participants	20 participants n=7 Participants	68 participants n=5 Participants
Diabetes	13 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 240 min

percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure

Outcome measures

Measure	Substrate Ablation n=105 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control n=47 Participants The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure	95 Percentage of participants	60 Percentage of participants

SECONDARY outcome

Timeframe: 180 min

Outcome measures

Measure	Substrate Ablation n=105 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control n=47 Participants The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
% of Patients With Sinus Rhythm Conversion During the Procedure	71 % of participants	26 % of participants

SECONDARY outcome

Timeframe: up to 300 min

Outcome measures

Measure	Substrate Ablation n=105 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control n=47 Participants The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Radiofrequency Time (Min)	49.1 min	84.6 min

SECONDARY outcome

Timeframe: 18 Months post ablation

Population: Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation. Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)

% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.

Outcome measures

Measure	Substrate Ablation n=96 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control n=44 Participants The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation	89 % of participants	42 % of participants

SECONDARY outcome

Timeframe: 18 months post ablation

Population: Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation. Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)

Adverse events

Outcome measures

Measure	Substrate Ablation n=96 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control n=44 Participants The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Number of Patients With Major Adverse Events During and up to 18 Months After Procedure	1 participants	1 participants

SECONDARY outcome

Timeframe: from first AF episode to baseline

duration of the longest AF epiodes in months before ablation

Outcome measures

Measure	Substrate Ablation n=105 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control n=47 Participants The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Maximum Sustained AF Duration	12.2 months	19.4 months

SECONDARY outcome

Timeframe: baseline

Left Atrial volume before ablation in ml

Outcome measures

Measure	Substrate Ablation n=105 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Mean LA Volume	168 ml Standard Deviation 45	—

SECONDARY outcome

Timeframe: baseline

Spontaneous AF at the beginning of the procedure

Outcome measures

Measure	Substrate Ablation n=105 Participants Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation	Historical Control The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
Spontaneous AF at the Beginning of the Procedure	65 Participants	—

Adverse Events

Substrate Ablation

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Historical Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Substrate Ablation n=105 participants at risk Study population (n=105)	Historical Control n=47 participants at risk Validation set (n=47)
Cardiac disorders Redo Pericardial effusion	0.95% 1/105 • Number of events 1 • from ablation to 18 month follow up	0.00% 0/47 • from ablation to 18 month follow up

Other adverse events

Adverse event data not reported

Additional Information

Dr Julien Seitz

Saint joseph hospital

Phone: +330491807044

Email: jseitz@hopital-saint-joseph.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place