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

NCT ID: NCT01445925

Last Updated: 2013-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulmonary vein isolation

Patients will undergo pulmonary venous isolation plus pharmacological substrate modification

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation (PVI)

Intervention Type: 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

Pharmacological Substrate modification

Intervention Type: DRUG

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

Pulmonary vein isolation + Linear Lesions

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

Group Type: EXPERIMENTAL

Pulmonary vein isolation + linear lesions

Intervention Type: 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.

Pharmacological Substrate modification

Intervention Type: DRUG

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

Interventions

Pulmonary vein isolation (PVI)

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

Intervention Type: PROCEDURE

Pulmonary vein isolation + linear lesions

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.

Intervention Type: PROCEDURE

Pharmacological Substrate modification

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Dhiraj Gupta

Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dhiraj Gupta, MD DM MRCP

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart and Chest Hospital

Locations

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Royal Brompton and Harefield Hospitals NHS Trust

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 25588685 (View on PubMed)

Other Identifiers

LHCH901

Identifier Type: -

Identifier Source: org_study_id