Trial Outcomes & Findings for Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps (NCT NCT01581437)

NCT ID: NCT01581437

Last Updated: 2016-03-11

Results Overview

To determine where atypical areas of drivers might be.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: 30 min
• Results posted on: 2016-03-11

Participant Flow

Participant milestones

Measure	64 Pole Basket Catheter all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Overall Study STARTED	78
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps

Baseline characteristics by cohort

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants
Atrial Fibrillation persisitent atrial fibrillation	48 participants n=5 Participants
Atrial Fibrillation longstanding persisitent atrial fibrillation	7 participants n=5 Participants
Atrial Fibrillation paroxysmal atrial fibrillation	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 min

To determine where atypical areas of drivers might be.

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Percentage of Drivers in Right Atrial	25.3 percentage of rotor sources

PRIMARY outcome

Timeframe: 30 minutes

Population: patients participating undergo mapping using the 64 pole basket catheter

total time taken to ablate all sources of rotors/focal sources in driver locations

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Time to Ablation of All Sources	16.6 minutes Standard Deviation 11.7

PRIMARY outcome

Timeframe: 30 minutes

percentage of patients

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources	50 percentage of patients

PRIMARY outcome

Timeframe: 30 minutes

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Average Number of Rotors/Focal Drivers in Diverse Locations	2.3 rotor/focal drivers Standard Deviation 0.9

SECONDARY outcome

Timeframe: 30 min

To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs	78 participants

SECONDARY outcome

Timeframe: 1 year

Population: patients participating undergo mapping using the 64 pole basket catheter

mean time to recurrence of atrial fibrillation

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Mean Time to Recurrence of Atrial Fibrillation	245 days Interval 0.0 to 365.0

SECONDARY outcome

Timeframe: one year

Population: percentage of patients who underwent mapping with 64 pole basket catheter

percentage of patients without prior ablation

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Single-procedure Freedom From Atrial Fibrillation	87.5 percentage of patients with no prior abl

SECONDARY outcome

Timeframe: 1 year

Population: all patients participating undergo mapping using the 64 pole basket catheter

percentage of all patients who had ablation perfornmed

Outcome measures

Measure	64 Pole Basket Catheter n=78 Participants all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation 64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation	80.5 percentage of all patients undergoing ab

Adverse Events

64 Pole Basket Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenneth Ellenbogen

Virginia CU

Phone: 804-828-7565

Email: kellenbogen@mcvh-vcu.edu

Results disclosure agreements

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