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Procedure

Intervention for Heart Failure (CONVERGE-HF Trial)

N/A

Waitlist Available

Led By Ayman Hussein, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have 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)

Be >18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

CONVERGE-HF Trial Summary

This trial is a small study that aims to test the feasibility and effectiveness of two different treatments for a certain condition. The study will randomly assign 50 patients to receive either a hybrid ablation or a

Who is the study for?

This trial is for individuals with heart failure and persistent atrial fibrillation. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria to be considered.Check my eligibility

What is being tested?

The study is testing two procedures: hybrid ablation and catheter ablation, in patients with heart failure and atrial fibrillation. It's a small-scale pilot trial where 50 patients will be randomly assigned to one of the two treatments.See study design

What are the potential side effects?

Potential side effects for both interventions may include bleeding, infection at the site of surgery, blood vessel damage, or heart rhythm problems post-procedure.

CONVERGE-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's left atrium is enlarged but not extremely large.

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I am older than 18 years.

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I have had atrial fibrillation that has lasted a long time.

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I can walk for 6 minutes without assistance.

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I am a candidate for heart rhythm correction procedures and medications.

CONVERGE-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of Major Adverse Event Rate after blanking period post procedure

Secondary outcome measures

AF burden

All-cause mortality

Cerebrovascular accidents

+11 more

CONVERGE-HF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

Catheter ablation including PVI and posterior wall ablation

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,028 Previous Clinical Trials

1,364,428 Total Patients Enrolled

32 Trials studying Heart Failure

13,958 Patients Enrolled for Heart Failure

AtriCure, Inc.Industry Sponsor

41 Previous Clinical Trials

17,421 Total Patients Enrolled

Ayman Hussein, MDPrincipal InvestigatorThe Cleveland Clinic

1 Previous Clinical Trials

70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"As per clinicaltrials.gov, the current status of this trial indicates that it is not actively seeking participants. The trial was initially posted on February 1st, 2024 and last edited on December 13th, 2023. However, there are currently a total of 1238 other ongoing clinical trials actively recruiting patients for various medical studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure

2024. "Hybrid Persistent Atrial Fibrillation Ablation in Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06182566.