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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03811938
Other study ID # IRAS 202816
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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