Status:
WITHDRAWN
Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
AtriCure, Inc.
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 persiste...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06182566
Start Date
July 1 2024
End Date
July 1 2027
Last Update
July 19 2024
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