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

A Pilot Randomized Trial of Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure CONVERGE-HF

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

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation; Procedure: Convergent 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Catheter ablation including PVI and posterior wall ablation	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
Experimental: Intervention; Convergent ablation Surgical epicardial ablation/ LAA clip/ ablation of ligament of Marshall Catheter Ablation including PVI and posterior wall ablation	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF burden	Percentage of AF out of the total monitored time	up to 2 years
Death from cardiovascular causes	Occurrence of death from cardiovascular causes	up to 2 years
Worsening of Heart Failure	Occurrence of worsening of heart failure defined as: hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies	up to 2 years
Need for continuation of Antiarrhythmic drug(s) beyond the blanking period	Occurrence of worsening of heart failure defined as: hospitalization, visits for IV diuresis or escalation to advanced heart failure therapies	3 month post procedure up to 2 years
Redo ablation beyond the blanking period	Occurrence of arrhythmia requiring redo ablation	3 month post procedure up to 2 years
Total number of cardiovascular hospitalizations	Number of cardiovascular-related hospitalizations	Up to 2 years
Recurrence of AF lasting more than 30 seconds	Number of occurrence of AF lasting more than 30 seconds	Up to 2 years
Change in distance walked in 6-minute walk test	Change in meters walked in 6-minute walk test compared to baseline	up to 2 years
Change in MLHF Quality of Life	Based on composite score (0-105). Each item is scored in a 6-point Likert Scale (0 = none to 5 = very much), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. Score is compared to baseline.	up to 2 years
All-cause mortality	Occurrence of death from all-cause	up to 2 years
Unplanned hospitalization due to cardiovascular reasons	Occurrence of unplanned hospitalizations for cardiovascular reasons	up to 2 years
Worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies	Occurrence of worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies requiring: LV mechanical assist devices, transplant, intravenous inotropes	up to 2 years
Cerebrovascular accidents	Occurrence of cardiovascular accidents	up to 2 years
Change in EF during trial period	EF percentage change compared to baseline	up to 2 years

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: AtriCure, Inc.
• Investigators: Principal Investigator: Ayman Hussein, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: Withdrawn

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No