Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure

NCT06182566 | Withdrawn DMC

• 1 other identifier: Withdrawn
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Atrial Fibrillation; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• AF burden

  up to 2 years

• Death from cardiovascular causes

  up to 2 years

• Worsening of Heart Failure

  up to 2 years

• Need for continuation of Antiarrhythmic drug(s) beyond the blanking period

  3 month post procedure up to 2 years

• Redo ablation beyond the blanking period

  3 month post procedure up to 2 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Catheter ablation including PVI and posterior wall ablation

Procedure: Catheter ablation

Intervention

EXPERIMENTAL

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

Procedure: Convergent ablation

Interventions

Convergent ablation 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

Intervention

Catheter ablation 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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• AtriCure, Inc.: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ayman Hussein, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 19, 2024

Record last verified: 2024-07