Atrial Fibrillation, Heart Failure
Conditions
Brief summary
Pilot, randomized, unblinded, feasibility and proof of concept clinical trial randomizing 50 patients in a 1:1 ratio to hybrid ablation or catheter ablation
Detailed description
To determine if a hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent AF. Hypothesis: Hybrid convergent ablation procedure with atrial appendage clip is superior to catheter ablation in the management of heart failure patients with persistent and longstanding persistent AF in terms of mortality and worsening heart failure, AF rhythm control and improvement in LVEF, quality of life, and 6-minute walk distance.
Interventions
PROCEDUREConvergent ablation
Staged hybrid ablation with CONVERGENT epicardial ablation with ablation of the ligament of Marshall and left atrial appendage clip, followed in second stage by endocardial catheter ablation including pulmonary vein isolation and posterior wall ablation with roof and inferior posterior lines in addition to targeting and touching up any areas with signals at the posterior wall
PROCEDURECatheter ablation
Pulmonary vein isolation using commercially available catheters; including pulmonary vein isolation and posterior wall ablation with roof and inferior posterior lines in addition to targeting and touching up any areas with signals at the posterior wall
Sponsors
AtriCure, Inc.
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria: * Be \>18 years of age * Provide signed written Informed Consent * Persistent or longstanding persistent AF * Heart failure with LV systolic dysfunction (defined as EF\<40%) and prior hospitalization for heart failure in the preceding 12 months (randomization will account for 2 strata \>30% vs \<30% to ensure balanced enrollment) * Moderate or severe left atrial enlargement (Left atrial diameter\>45 mm and not exceeding 60 mm; or indexed LA volume \>40 ml/m2 and not exceeding 110 ml/ m2) * Ability to complete 6 minute walk test * Negative pregnancy test for female patients of child bearing potential. * Be eligible for ablation and anti-arrhythmic drugs
Exclusion criteria
Subjects must meet none of the criteria: * Very severe left atrial enlargement with diameter \>60 mm or indexed LA Volume \>110 mL/m2 * Stroke or myocardial infarction within the preceding 3 months * Reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma * Presently with Valvular Heart disease requiring surgical intervention * Presently with coronary artery disease requiring surgical or percutaneous intervention * Early Post-operative AF (within three months of surgery) * History of AVN ablation * Liver Failure * Renal Failure requiring dialysis * Social factors that would preclude follow up or make compliance difficult. * Contraindication to the use of appropriate anticoagulation therapy * Enrollment in another investigational drug or device study. * Patients with severe pulmonary disease * Documented intra-atrial thrombus, tumor, or another structural abnormality which precludes ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Major Adverse Event Rate after blanking period post procedure | Up to 2 years | Major Adverse Events consist of death from cardiovascular causes, worsening of heart failure defined as hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies; need for continuation of AADs or redo ablation for recurrent arrhythmias beyond the blanking period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death from cardiovascular causes | up to 2 years | Occurrence of death from cardiovascular causes |
| Worsening of Heart Failure | up to 2 years | Occurrence of worsening of heart failure defined as: hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies |
| Need for continuation of Antiarrhythmic drug(s) beyond the blanking period | 3 month post procedure up to 2 years | Occurrence of worsening of heart failure defined as: hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies |
| Redo ablation beyond the blanking period | 3 month post procedure up to 2 years | Occurrence of arrhythmia requiring redo ablation |
| Total number of cardiovascular hospitalizations | Up to 2 years | Number of cardiovascular-related hospitalizations |
| Recurrence of AF lasting more than 30 seconds | Up to 2 years | Number of occurrence of AF lasting more than 30 seconds |
| AF burden | up to 2 years | Percentage of AF out of the total monitored time |
| Change in MLHF Quality of Life | up to 2 years | Based on composite score (0-105). Each item is scored in a 6-point Likert Scale (0 = none to 5 = very much), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. Score is compared to baseline. |
| Change in EF during trial period | up to 2 years | EF percentage change compared to baseline |
| All-cause mortality | up to 2 years | Occurrence of death from all-cause |
| Unplanned hospitalization due to cardiovascular reasons | up to 2 years | Occurrence of unplanned hospitalizations for cardiovascular reasons |
| Worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies | up to 2 years | Occurrence of worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies requiring: LV mechanical assist devices, transplant, intravenous inotropes |
| Cerebrovascular accidents | up to 2 years | Occurrence of cardiovascular accidents |
| Change in distance walked in 6-minute walk test | up to 2 years | Change in meters walked in 6-minute walk test compared to baseline |
Outcome results
None listed