Clinical trial NCT06182566: Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure
Official title: A Pilot Randomized Trial of Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure CONVERGE-HF
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Heart Failure
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
First posted: 2023-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite of Major Adverse Event Rate after blanking period post procedure
timeFrame: Up to 2 years
Secondary outcomes:
measure: AF burden
timeFrame: up to 2 years
measure: Death from cardiovascular causes
timeFrame: up to 2 years
measure: Worsening of Heart Failure
timeFrame: up to 2 years
measure: Need for continuation of Antiarrhythmic drug(s) beyond the blanking period
timeFrame: 3 month post procedure up to 2 years
measure: Redo ablation beyond the blanking period
timeFrame: 3 month post procedure up to 2 years
measure: Total number of cardiovascular hospitalizations
timeFrame: Up to 2 years
measure: Recurrence of AF lasting more than 30 seconds
timeFrame: Up to 2 years
measure: Change in distance walked in 6-minute walk test
timeFrame: up to 2 years
measure: Change in MLHF Quality of Life
timeFrame: up to 2 years
measure: Change in EF during trial period
timeFrame: up to 2 years
measure: All-cause mortality
timeFrame: up to 2 years
measure: Unplanned hospitalization due to cardiovascular reasons
timeFrame: up to 2 years
measure: Worsening heart failure requiring unplanned hospitalization or escalation to advanced heart failure therapies
timeFrame: up to 2 years
measure: Cerebrovascular accidents
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Ayman Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References: