Heart Failure Clinical Trial
— CONVERGE-HFOfficial title:
A Pilot Randomized Trial of Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure CONVERGE-HF
Pilot, randomized, unblinded, feasibility and proof of concept clinical trial randomizing 50 patients in a 1:1 ratio to hybrid ablation or catheter ablation
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | July 1, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | AtriCure, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of Major Adverse Event Rate after blanking period post procedure | 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. | Up to 2 years | |
Secondary | AF burden | Percentage of AF out of the total monitored time | up to 2 years | |
Secondary | Death from cardiovascular causes | Occurrence of death from cardiovascular causes | up to 2 years | |
Secondary | Worsening of Heart Failure | Occurrence of worsening of heart failure defined as: hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies | up to 2 years | |
Secondary | Need for continuation of Antiarrhythmic drug(s) beyond the blanking period | Occurrence of worsening of heart failure defined as: hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies | 3 month post procedure up to 2 years | |
Secondary | Redo ablation beyond the blanking period | Occurrence of arrhythmia requiring redo ablation | 3 month post procedure up to 2 years | |
Secondary | Total number of cardiovascular hospitalizations | Number of cardiovascular-related hospitalizations | Up to 2 years | |
Secondary | Recurrence of AF lasting more than 30 seconds | Number of occurrence of AF lasting more than 30 seconds | Up to 2 years | |
Secondary | Change in distance walked in 6-minute walk test | Change in meters walked in 6-minute walk test compared to baseline | up to 2 years | |
Secondary | Change in MLHF Quality of Life | 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. |
up to 2 years | |
Secondary | Change in EF during trial period | EF percentage change compared to baseline | up to 2 years | |
Secondary | All-cause mortality | Occurrence of death from all-cause | up to 2 years | |
Secondary | Unplanned hospitalization due to cardiovascular reasons | Occurrence of unplanned hospitalizations for cardiovascular reasons | up to 2 years | |
Secondary | Worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies | Occurrence of worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies requiring: LV mechanical assist devices, transplant, intravenous inotropes | up to 2 years | |
Secondary | Cerebrovascular accidents | Occurrence of cardiovascular accidents | up to 2 years |
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