Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure (CONVERGE-HF)

NeuroTherapia, Inc.

Status: Withdrawn

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Procedure: Catheter ablation; Procedure: Convergent ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06182566

Withdrawn

Details and patient eligibility

About

Pilot, randomized, unblinded, feasibility and proof of concept clinical trial randomizing 50 patients in a 1:1 ratio to hybrid ablation or catheter ablation

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control

Active Comparator group

Description:

Catheter ablation including PVI and posterior wall ablation

Treatment:

Procedure: Catheter ablation

Intervention

Experimental group

Description:

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

Treatment:

Procedure: Convergent ablation