Heart Failure Clinical Trial

Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

50

Study ID:

NCT06182566

Recruitment Status:

Not yet recruiting

Sponsor:

The Cleveland Clinic

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There is 1 Location for this study

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Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Ayman Hussein, MD
Contact
216-444-6171
[email protected]
Kathleen Davey, RN
Contact
216-445-7837
[email protected]
Edward Soltesz, MD
Sub-Investigator
Oussama Wazni, MD
Sub-Investigator
Walid Saliba, MD
Sub-Investigator
Wilson Tang, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

50

Study ID:

NCT06182566

Recruitment Status:

Not yet recruiting

Sponsor:


The Cleveland Clinic

How clear is this clinincal trial information?

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