Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF

NCT ID: NCT02492256

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-08-31

Brief Summary

Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical outcome in patients with persistent AF.

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

PVI group

Conventional PVI by circumferential antral ablation according to standard procedures.

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation

Intervention Type: DEVICE

CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. Conventional PVI by circumferential antral ablation according to standard procedures. Exit and Entrance block conformation. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.

ILR implantation

Intervention Type: DEVICE

Implantation the ECG loop recorder according to standard procedure

PVI+GP guided by SUMO technology group

Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology.

Group Type: EXPERIMENTAL

GP ablation guided by SUMO technology

Intervention Type: DEVICE

CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). RF Ablation of SUMO hotspots (in sinus rhythm if AF converts)

• Target a region of 1.0-1.5 cm diameter around the SUMO 'hotspot'. Control HFS. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.

ILR implantation

Intervention Type: DEVICE

Implantation the ECG loop recorder according to standard procedure

Interventions

Pulmonary vein isolation

CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. Conventional PVI by circumferential antral ablation according to standard procedures. Exit and Entrance block conformation. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.

Intervention Type: DEVICE

GP ablation guided by SUMO technology

CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). RF Ablation of SUMO hotspots (in sinus rhythm if AF converts)

• Target a region of 1.0-1.5 cm diameter around the SUMO 'hotspot'. Control HFS. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.

Intervention Type: DEVICE

ILR implantation

Implantation the ECG loop recorder according to standard procedure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female patients, age ≥ 18 and ≤ 80 years.

2. Persistent AF (ECG documentation).

3. Indication for AF ablation.

4. LVEF ≥ 50%

5. Able to provide written informed consent

6. Able to comply with the requirements of the study

Exclusion Criteria

1. Reversible cause of atrial fibrillation

2. Previous AF ablation therapy

3. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality

4. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)

5. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol

6. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures

7. Inability to undergo D-SPECT and CT imaging

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexander Romanov, MD, PhD

Role: CONTACT

abromanov@mail.ru

Marina Nikitenko

Role: CONTACT

m_nikitenko@meshalkin.ru

Facility Contacts

Evgeny Pokushalov, MD, PhD

Role: primary

E.Pokushalov@gmail.com

+79139254858

Other Identifiers

SPT15429

Identifier Type: -

Identifier Source: org_study_id