Persistent Atrial Fibrillation Clinical Trial
— CLIP-AFOfficial title:
Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | October 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age > 18 years; < 80 years - Persistent AF > 1-year duration - Left atrium size < 6cm - Pts should be able to provide written informed consent. Exclusion Criteria: - Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments. - Subject has a reversible cause of AF or transient AF - Subject is absent of LAA or if the LAA is previously surgically ligated - Subject has had previous cardiac surgery or abdominal surgery. - Subject has contraindication to anticoagulation. - Patients with hypertrophic cardiomyopathy. - Patients with significant valve disease. - Subject has had previous catheter or surgical ablation |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Bartholomew's Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Barts & The London NHS Trust | AtriCure, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demonstrate trial feasibility with regards to recruitment rate | Recruitment rate to the Convergent Procedure (with LARIAT) and radiofrequency ablation in the cohort of patients with our specific inclusion criteria will be measured. | 24 months | |
Primary | A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured. | Primary safety endpoint was a composite of major adverse events (MAE) and complications occurring within 30 days post procedure. Any of the following endpoints counted as a MAE: death, stroke/transient ischaemic attack, myocardial infarction, pericarditis requiring pericardiocentesis or prolongation of hospital stay or readmission, cardiac perforation/tamponade, bleeding at vascular access site requiring intervention, pneumothorax requiring intervention (after removal of chest drain, symptomatic pulmonary vein stenosis > 70%, permanent phrenic nerve paralysis, atrio-oesophageal fistula, major vascular complications and infection at surgical or puncture site requiring surgical intervention. | 30 days post procedure | |
Primary | Success or failure at 12 months of persistent AF patients to be free of: Atrial arrhythmia (classed as documentation of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds) | Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications | Measured from the end of a 3 month blanking period to 12 months post procedure | |
Primary | Measure improvement in symptoms following convergent ablation | Measure change in quality of life through the European Heart Rhythm Association (EHRA) patient survey which categorises patients symptoms during physical activity in 4 categories. The higher the class, the greater the severity of symptoms with Class 1 indication no symptoms and Class 4 indicating disabling symptoms with discontinuation of normal daily activity. | 12 months | |
Secondary | Measure improvement in symptoms following convergent ablation. | To measure improvement in quality of life assessment measured through the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire) to be performed at baseline, 6 months and 12 months post procedure. This survey employs the use of 20 questions regarding symptoms, effect on daily activities, treatment concerns and treatment satisfaction to generate a score from 0 - 100. The lower the score, the more severe the disability with score 0 indicating complete disability and score 100 indicating no disability or limitation in daily activities. | 12 months | |
Secondary | Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured. | Assessment of LVEF via transthoracic echocardiogram at baseline and transthoracic echocardiogram at 12 months post procedure. | 12 months | |
Secondary | Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation. | Assessment of heart failure symptoms and functional status via clinic review at baseline and 12 months post-procedure. | 12 months |
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