Atrial Fibrillation, Atrial Tachyarrhythmia
Conditions
Keywords
Atrial Fibrillation, Ablation
Brief summary
The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.
Interventions
None listed
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (AF) after having failed \>or= 1 anti-arrhythmic drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Free of Atrial Fibrillation | 6 -12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Termination or Slowing of Atrial Fibrillation During Ablation | acute | Using 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment from medical clinic.
Pre-assignment details
Recruitment from medical clinic.
Participants by arm
| Arm | Count |
|---|---|
| FIRM-Guided Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI) | 36 |
| 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. | 71 |
| Total | 107 |
Baseline characteristics
| Characteristic | CONVENTIONAL | FIRM-Guided | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 12 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 24 Participants | 79 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 8 | 63 years STANDARD_DEVIATION 9 | 62 years STANDARD_DEVIATION 8 |
| Gender Female | 3 Participants | 2 Participants | 5 Participants |
| Gender Male | 68 Participants | 34 Participants | 102 Participants |
| Region of Enrollment United States | 71 participants | 36 participants | 107 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 71 |
| serious Total, serious adverse events | 2 / 36 | 6 / 71 |
Outcome results
Primary
Survival Free of Atrial Fibrillation
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.
Time frame: 6 -12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FIRM-Guided | Survival Free of Atrial Fibrillation | 28 participants |
| CONVENTIONAL | Survival Free of Atrial Fibrillation | 31 participants |
Secondary
Termination or Slowing of Atrial Fibrillation During Ablation
Using 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.
Time frame: acute
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FIRM-Guided | Termination or Slowing of Atrial Fibrillation During Ablation | 31 Participants |
| CONVENTIONAL | Termination or Slowing of Atrial Fibrillation During Ablation | 13 Participants |