Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)

NCT01445925 | Unknown

• 1 other identifier: LHCH901
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.

  Defined as \>30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.

  12 months

Study Arms (2)

Pulmonary vein isolation

ACTIVE COMPARATOR

Patients will undergo pulmonary venous isolation plus pharmacological substrate modification

Procedure: Pulmonary vein isolation (PVI); Drug: Pharmacological Substrate modification

Pulmonary vein isolation + Linear Lesions

EXPERIMENTAL

Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification

Procedure: Pulmonary vein isolation + linear lesions; Drug: Pharmacological Substrate modification

Interventions

Pulmonary vein isolation (PVI) PROCEDURE

Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions \>2 mm outside pulmonary vein (PV) ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA). A 20-pole PV mapping catheter will be used to confirm electrical isolation. If the patient is in atrial fibrillation at this stage, sinus rhythm would be restored with electrical cardioversion and PVI would be confirmed in sinus rhythm

Pulmonary vein isolation

Pulmonary vein isolation + linear lesions PROCEDURE

Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions \>2 mm outside PV ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA)34. A 20-pole PV mapping catheter will be used to confirm electrical isolation. Once PVI has been achieved, patients will go onto to receive additional linear ablation lesions. These will include a left atrial roof line, mitral isthmus line, (including ablation inside the coronary sinus if necessary), and ablation on the cavotricuspid isthmus. If the patient is in atrial fibrillation at this stage, the acute end-point would be signal obliteration at the ablated area. Once sinus rhythm is restored with electrical cardioversion, PVI would be confirmed in sinus rhythm and conduction block across the LA roof line, Mitral line and CTI will then be verified with appropriate pacing manoeuvres.

Pulmonary vein isolation + Linear Lesions

Pharmacological Substrate modification DRUG

at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.

Pulmonary vein isolation; Pulmonary vein isolation + Linear Lesions

Eligibility Criteria

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

You may qualify if:

• Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
• Non-paroxysmal atrial fibrillation, as pre-classified as
• Persistent AF: AF requiring Electrical/ Chemical cardioversion or that lasting \>7 days. These patients may be in AF or in sinus Rhythm at the time of their initial assessment and/ or at the time of their ablation.
• Continuous Persistent AF: These patients are persistently in AF with or without antiarrhythmic drug therapy, as confirmed on a 24 hour Holter. They may have undergone previous cardioversion(s).
• Sustained Paroxysmal AF with underlying substrate: Patients with Individual AF episode(s) lasting \>12 hours but less than 7 days plus one or more of the following:
• Age \>65 years 21
• Individual AF episode(s) lasting \>24 hours
• Significant left atrial dilatation of \>45 mm on Echo (Parasternal Long Axis view)
• Obesity (Body Mass Index \>30), and/ or history suggestive of sleep apnoea
• Diabetes Mellitus requiring hypoglycaemic drugs and/or Insulin

You may not qualify if:

• Inability or unwillingness to receive oral anticoagulation with warfarin
• Previous Ablation procedure for AF
• Unwillingness or inability to complete the required follow up arrangements
• Presence of long standing persistent AF with continuous AF longer than 12 months. This includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
• Documented typical atrial flutter
• Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
• Contraindications and/ or prior intolerance to both Amiodarone and Flecainide.
• Reversible cause for atrial fibrillation
• Known hypertrophic or infiltrative cardiomyopathy

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead

Study Sites (2)

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Royal Brompton and Harefield Hospitals NHS Trust

London, United Kingdom

Location

Related Publications (1)

• Wynn GJ, DAS M, Bonnett LJ, Hall MCS, Snowdon RL, Waktare JEP, Modi S, Todd DM, Gupta D. A novel marker to predict early recurrence after atrial fibrillation ablation: the ablation effectiveness quotient. J Cardiovasc Electrophysiol. 2015 Apr;26(4):397-403. doi: 10.1111/jce.12618. Epub 2015 Feb 25.

  PMID: 25588685 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Dhiraj Gupta, MD DM MRCP

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 4, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

GB (2)