Ablation of Low Voltage Regions in Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— ABLOVO-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811938
• Other study ID #: IRAS 202816
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: June 2020

Study information

• Verified date: January 2019
• Source: Imperial College London
• Contact: Szabolcs Nagy, MD
• Phone: 447821694566
• Email: s.nagy[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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.
• Pulmonary Vein Isolation
Catheter ablation aiming for the electrical isolation of the pulmonary veins.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Abbott

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Antiarrhythmic drugs	Change in the number of antiarrhythmic drugs per patient	3-12 months
Secondary	Number of AF ablations	Number of additional AF ablations	3-12 months
Secondary	Complication rate	Number and rate of complications in the study population.	3-12 months