Ablation of Low Voltage Regions in Persistent Atrial Fibrillation (ABLOVO-AF)

Catheter ABlation of Low Voltage Regions in the Treatment of Persistent Atrial Fibrillation (ABLOVO-AF Study)

Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofrequency ablation (RFA). This technology works by heating heart muscle inside the heart to break the electrical circuits responsible for the abnormal rhythm.

The energy is delivered into the heart with plastic tubes that have metal electrodes, inserted through the groin veins and removed after the procedure. The patient is usually put to sleep during the intervention.

If the AF has been present for more than seven days but for less than one year it is called persistent, and it can be difficult to treat successfully with the usual methods.

Goals. The study will test a new RFA technique to treat patients with persistent AF. This involves identifying areas within the left upper chamber that have a lower electrical voltage than the surrounding heart muscle and applying RFA to the border zones of these areas.

Methods. The new technology combined with the usual procedure will be compared to the usual procedure alone. All patients will receive ablation according to the new technique and results will be compared to a historical control group from the trial institution.

Follow up. Patients will be followed up for 12 months with clinic visits and heart rhythm checks.

Potential benefit. The new technique will be assessed for success at keeping patients free from persistent AF compared to the usual methods.

The study will be performed at Imperial College Healthcare NHS Trust, at the Hammersmith Hospital. Licensed clinical software will be used from St Jude Medical to guide ablation and a special research software module will be used to analyse data from the heart following ablation. The study will be sponsored by Imperial College Healthcare NHS Trust

Study Overview

• Status: Unknown
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Pulmonary Vein Isolation; Procedure: Low voltage ablation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Hammersmith Hospital
    • Contact: Szabolcs Nagy, MD; Phone Number: 447821694566; Email: s.nagy@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Suitable candidate for catheter mapping/ablation for arrhythmias.
2. Eighteen (18) to eighty-five (85) years of age
3. Body Mass Index (BMI) < 40 (Wt. in Kgs / Ht. in m2)
4. Signed Informed Consent

Exclusion Criteria:

1. Severe cerebrovascular disease
2. Moderate to severe renal impairment (eGFR < 30)
3. Active gastrointestinal bleeding
4. Active infection or fever
5. Short life expectancy
6. Significant anemia
7. Severe uncontrolled systemic hypertension
8. Severe electrolyte imbalance
9. Ejection fraction of < 35%
10. Congestive heart failure (NYHA Class IV)
11. Unstable angina requiring emergent PTCA (percutaneous transluminal coronary angioplasty) or CABG (coronary artery bypass graft)
12. Recent myocardial infarction
13. Bleeding or clotting disorders
14. Uncontrolled diabetes
15. Inability to receive IV or oral Anticoagulants
16. Unable to give informed consent (these patients would not be recruited)
17. Previous catheter or surgical ablation treatment for atrial fibrillation.
18. Paroxysmal atrial fibrillation.
19. Pregnancy (urinary pregnancy test will be offered on the day of the procedure for all women of reproductive age)
20. Drug and/or alcohol abuse
21. Transient factors for AF
22. Severe LA enlargement of >60 mm in diameter on echocardiography
23. Patients who have participated in another study of an investigational medicinal product in the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pulmonary Vein Isolation; Historical control from cases performed in year 2017 at Hammersmith Hospital. Intervention: Pulmonary vein isolation.	Procedure: Pulmonary Vein Isolation; Catheter ablation aiming for the electrical isolation of the pulmonary veins.
Experimental: Low voltage ablation; Active arm, Intervention: Standard pulmonary vein isolation and Low Voltage Ablation.	Procedure: Low voltage ablation; Catheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation recurrence	Recurrence of atrial arrhythmia of at least 30s in duration. Investigation period for arrhythmia recurrence will be between 3 and 12 months after the first procedure, allowing for a blanking period of 3 months.	3-12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Cardiovascular Society Severity in Atrial Fibrillation Score	Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) change. 0 represents no symptoms, 4 represents symptoms that significantly interfere with quality of life and exercise capacity.	12 months
Antiarrhythmic drugs	Change in the number of antiarrhythmic drugs per patient	3-12 months
Number of AF ablations	Number of additional AF ablations	3-12 months
Complication rate	Number and rate of complications in the study population.	3-12 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Abbott
• Investigators: Principal Investigator: Phang B Lim, MB BChir, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Radiofrequency Catheter Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IRAS 202816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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