Trial Outcomes & Findings for The Dynamics of Human Atrial Fibrillation (NCT NCT01008722)
NCT ID: NCT01008722
Last Updated: 2017-02-08
Results Overview
Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as \>30 seconds.
Recruitment status
COMPLETED
Target enrollment
98 participants
Primary outcome timeframe
6 -12 months
Results posted on
2017-02-08
Participant Flow
Recruitment from medical clinic.
Recruitment from medical clinic.
Participant milestones
| Measure |
FIRM-Guided
Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
|
CONVENTIONAL
Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
71
|
|
Overall Study
COMPLETED
|
36
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Dynamics of Human Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
FIRM-Guided
n=36 Participants
Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
|
CONVENTIONAL
n=71 Participants
Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9 • n=5 Participants
|
61 years
STANDARD_DEVIATION 8 • n=7 Participants
|
62 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
34 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
71 participants
n=7 Participants
|
107 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 -12 monthsUsing data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as \>30 seconds.
Outcome measures
| Measure |
FIRM-Guided
n=34 Participants
Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
|
CONVENTIONAL
n=69 Participants
Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
|
|---|---|---|
|
Survival Free of Atrial Fibrillation
|
28 participants
|
31 participants
|
SECONDARY outcome
Timeframe: acuteUsing data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus.
Outcome measures
| Measure |
FIRM-Guided
n=36 Participants
Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
|
CONVENTIONAL
n=65 Participants
Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
|
|---|---|---|
|
Termination or Slowing of Atrial Fibrillation During Ablation
|
31 Participants
|
13 Participants
|
Adverse Events
FIRM-Guided
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
CONVENTIONAL
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FIRM-Guided
n=36 participants at risk
Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
|
CONVENTIONAL
n=71 participants at risk
Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
|
|---|---|---|
|
Cardiac disorders
Cardiac tamponade
|
2.8%
1/36 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Blood and lymphatic system disorders
Groin bleed requiring transfusion
|
2.8%
1/36 • Number of events 1
|
4.2%
3/71 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Symptomatic Pulmonary Vein Stenosis
|
0.00%
0/36
|
1.4%
1/71 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sanjiv Narayan (Professor of Medicine, Principal Investigator)
University of California, San Diego
Phone: (650) 498-8161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place