Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure

NCT ID: NCT06182566

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-07-01

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.

Conditions

Atrial Fibrillation; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Catheter ablation including PVI and posterior wall ablation

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: PROCEDURE

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

Intervention

Convergent ablation Surgical epicardial ablation/ LAA clip/ ablation of ligament of Marshall Catheter Ablation including PVI and posterior wall ablation

Group Type: EXPERIMENTAL

Convergent ablation

Intervention Type: PROCEDURE

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

Interventions

Convergent 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

Intervention Type: PROCEDURE

Catheter 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayman Hussein, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Other Identifiers

Withdrawn

Identifier Type: -

Identifier Source: org_study_id