Ablation of Low Voltage Regions in Persistent Atrial Fibrillation

NCT03811938 | Unknown

• 1 other identifier: IRAS 202816
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Persistent Atrial Fibrillation

Keywords

Radiofrequency Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Canadian Cardiovascular Society Severity in Atrial Fibrillation Score

  12 months

• Antiarrhythmic drugs

  3-12 months

• Number of AF ablations

  3-12 months

• Complication rate

  3-12 months

Study Arms (2)

Pulmonary Vein Isolation

ACTIVE COMPARATOR

Historical control from cases performed in year 2017 at Hammersmith Hospital. Intervention: Pulmonary vein isolation.

Procedure: Pulmonary Vein Isolation

Low voltage ablation

EXPERIMENTAL

Active arm, Intervention: Standard pulmonary vein isolation and Low Voltage Ablation.

Procedure: Low voltage ablation

Interventions

Low voltage ablation PROCEDURE

Catheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins.

Low voltage ablation

Pulmonary Vein Isolation PROCEDURE

Catheter ablation aiming for the electrical isolation of the pulmonary veins.

Pulmonary Vein Isolation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe cerebrovascular disease
• Moderate to severe renal impairment (eGFR \< 30)
• Active gastrointestinal bleeding
• Active infection or fever
• Short life expectancy
• Significant anemia
• Severe uncontrolled systemic hypertension
• Severe electrolyte imbalance
• Ejection fraction of \< 35%
• Congestive heart failure (NYHA Class IV)
• Unstable angina requiring emergent PTCA (percutaneous transluminal coronary angioplasty) or CABG (coronary artery bypass graft)
• Recent myocardial infarction
• Bleeding or clotting disorders
• Uncontrolled diabetes
• Inability to receive IV or oral Anticoagulants

Sponsors & Collaborators

• Imperial College London: lead
• Abbott: collaborator

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Phang B Lim, MB BChir

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Szabolcs Nagy, MD

CONTACT

447821694566; s.nagy@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 22, 2019
• Study Start: August 24, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)