Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure

Heart Failure Clinical Trial

— CONVERGE-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182566
• Other study ID #: pending
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: Ayman Hussein, MD
• Phone: 216-444-6171
• Email: husseia[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AF burden	Percentage of AF out of the total monitored time	up to 2 years
Secondary	Death from cardiovascular causes	Occurrence of death from cardiovascular causes	up to 2 years
Secondary	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
Secondary	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
Secondary	Redo ablation beyond the blanking period	Occurrence of arrhythmia requiring redo ablation	3 month post procedure up to 2 years
Secondary	Total number of cardiovascular hospitalizations	Number of cardiovascular-related hospitalizations	Up to 2 years
Secondary	Recurrence of AF lasting more than 30 seconds	Number of occurrence of AF lasting more than 30 seconds	Up to 2 years
Secondary	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
Secondary	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
Secondary	Change in EF during trial period	EF percentage change compared to baseline	up to 2 years
Secondary	All-cause mortality	Occurrence of death from all-cause	up to 2 years
Secondary	Unplanned hospitalization due to cardiovascular reasons	Occurrence of unplanned hospitalizations for cardiovascular reasons	up to 2 years
Secondary	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
Secondary	Cerebrovascular accidents	Occurrence of cardiovascular accidents	up to 2 years