Atrial Fibrillation Chronic, Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Long-Standing Atrial Fibrillation, Posterior Left Atrial Wall Ablation
Brief summary
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone. The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.
Detailed description
Patients with persistent or long-standing persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. All patients are required to be in atrial fibrillation (AF) on the day of the ablation procedure. After ablation (isolation) of the pulmonary veins (PVI) is complete, and while still in the electrophysiology lab, all patients are randomized to either PVI, alone \[Group 1\] or the combination of PVI plus ablation of the posterior left atrial wall (PLAW) \[Group 2\]. For those patients randomized to PVI, their ablation procedure is complete at this time. For those patients randomized to PVI plus PLAW, they will have the additional ablation to the posterior left atrial wall performed. All study patients have the same follow-up after their ablation procedure: clinic visits at 3, 6, and 13 months; a heart event monitor is worn for 7-14 days before these visits. An echocardiogram is done at 4-6 months after the ablation procedure. Blood thinners are usually recommended for three months after the ablation procedure and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the judgement of their study doctor. Information about patient's medical history, heart arrhythmias, and atrial fibrillation will be collected during the study. This information will be analyzed as part of the study.
Interventions
PROCEDURECryo or Radiofrequency (RF) Ablation only of Pulmonary Veins
Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins OR FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins. Ablation of the Pulmonary Veins alone
PROCEDURECryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW OR RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)
Sponsors
Arash Aryana, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females with an age \>18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted * All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements * Patients must be in AF on the day of the procedure
Exclusion criteria
* Any reversible cause of AF (post-operative, thyroid disorder, etc) * Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months * Patients with any corrected or uncorrected congenital heart disease * Patients with a history of hypertrophic cardiomyopathy * Patients with cardiomyopathy and a left ventricular ejection fraction \<35% * Congestive heart failure, class IV * Women who are known to be pregnant or have had a positive β-Human Chorionic Gonadotropin (β-HCG) test 7 days prior to procedure * Patients whose life expectancy is \<1 year * History of left-sided left atrial ablation (catheter or surgically-based) * Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Freedom From Recurrent Atrial Arrhythmias | One year | The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Complication Rate | During follow-up, assessed for an estimated total of one year. | The type and frequency of complications following catheter ablation |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulmonary Vein Isolation (PVI) Cryoablation only of Pulmonary Veins
or
Radiofrequency ablation only of Pulmonary Veins
Pulmonary Vein Isolation (PVI) alone.
Cryo or RF Ablation only of Pulmonary Veins: Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins
OR
FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins.
Ablation of the Pulmonary Veins alone | 55 |
| PVI & Posterior Left Atrial Ablation Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall
or
Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall
PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW)
Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW: Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW
OR
RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW
Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW) | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Pulmonary Vein Isolation (PVI) | PVI & Posterior Left Atrial Ablation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 29 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 26 Participants | 46 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 9 | 67 years STANDARD_DEVIATION 8 | 68.5 years STANDARD_DEVIATION 2.12 |
| Long-standing persistent atrial fibrillation | 17 Participants | 21 Participants | 38 Participants |
| Persistent atrial fibrillation | 38 Participants | 34 Participants | 72 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Japan | 29 participants | 34 participants | 63 participants |
| Region of Enrollment United States | 26 participants | 21 participants | 47 participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 33 Participants | 35 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 3 / 55 | 3 / 55 |
Outcome results
Primary
1-year Freedom From Recurrent Atrial Arrhythmias
The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation.
Time frame: One year
Population: Study cohort consisted of patients undergoing first-time cryoballoon ablation for symptomatic persistent/long-standing persistent atrial ablation (55 subjects in the PVI isolation arm and 55 subjects in the PVI+PWI arm) were analyzed for freedom from recurrence of atrial fibrillation and all atrial arrhythmias at one-year post-study ablation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulmonary Vein Isolation (PVI) | 1-year Freedom From Recurrent Atrial Arrhythmias | 25 Participants |
| PVI & Posterior Left Atrial Ablation | 1-year Freedom From Recurrent Atrial Arrhythmias | 14 Participants |
Secondary
Overall Complication Rate
The type and frequency of complications following catheter ablation
Time frame: During follow-up, assessed for an estimated total of one year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulmonary Vein Isolation (PVI) | Overall Complication Rate | 3 Participants |
| PVI & Posterior Left Atrial Ablation | Overall Complication Rate | 3 Participants |