Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure
- Conditions
- Heart FailureAtrial Fibrillation
- Interventions
- Procedure: Catheter ablationProcedure: Convergent ablation
- Registration Number
- NCT06182566
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Catheter ablation Catheter ablation including PVI and posterior wall ablation Intervention Convergent ablation Convergent ablation Surgical epicardial ablation/ LAA clip/ ablation of ligament of Marshall Catheter Ablation including PVI and posterior wall ablation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Total number of cardiovascular hospitalizations Up to 2 years Number of cardiovascular-related hospitalizations
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
Cerebrovascular accidents up to 2 years Occurrence of cardiovascular accidents
Death from cardiovascular causes up to 2 years Occurrence of death from cardiovascular causes
Redo ablation beyond the blanking period 3 month post procedure up to 2 years Occurrence of arrhythmia requiring redo ablation
Recurrence of AF lasting more than 30 seconds Up to 2 years Number of occurrence of AF lasting more than 30 seconds
All-cause mortality up to 2 years Occurrence of death from all-cause
AF burden up to 2 years Percentage of AF out of the total monitored time
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
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