Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology

NCT ID: NCT02914860

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-06-30

Brief Summary

The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Volunteers

Healthy volunteers

Group Type: EXPERIMENTAL

Cardiac CT

Intervention Type: DEVICE

• Cardiac CT - contract enhanced cardiac CT according to standard protocol
• D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)
• Merge CT and D-SPECT image data to generate SUMO map.

D-SPECT

Intervention Type: DEVICE

PAF

Patients with paroxysmal atrial fibrillation

Group Type: ACTIVE_COMPARATOR

Cardiac CT

Intervention Type: DEVICE

• Cardiac CT - contract enhanced cardiac CT according to standard protocol
• D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)
• Merge CT and D-SPECT image data to generate SUMO map.

Ablation Procedure

Intervention Type: PROCEDURE

1. CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO.

2. 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).

3. RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts)

4. Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA

5. Control HFS

6. At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.

7. Exit and entrance block confirmation

8. Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.

D-SPECT

Intervention Type: DEVICE

Pers AF

Patients with persistent atrial fibrillation

Group Type: ACTIVE_COMPARATOR

Cardiac CT

Intervention Type: DEVICE

• Cardiac CT - contract enhanced cardiac CT according to standard protocol
• D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)
• Merge CT and D-SPECT image data to generate SUMO map.

Ablation Procedure

Intervention Type: PROCEDURE

1. CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO.

2. 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).

3. RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts)

4. Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA

5. Control HFS

6. At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.

7. Exit and entrance block confirmation

8. Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.

D-SPECT

Intervention Type: DEVICE

L-s Pers AF

Patients with long-standing persistent atrial fibrillation

Group Type: ACTIVE_COMPARATOR

Cardiac CT

Intervention Type: DEVICE

• Cardiac CT - contract enhanced cardiac CT according to standard protocol
• D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)
• Merge CT and D-SPECT image data to generate SUMO map.

Ablation Procedure

Intervention Type: PROCEDURE

1. CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO.

2. 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).

3. RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts)

4. Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA

5. Control HFS

6. At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.

7. Exit and entrance block confirmation

8. Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.

D-SPECT

Intervention Type: DEVICE

Interventions

Cardiac CT

• Cardiac CT - contract enhanced cardiac CT according to standard protocol
• D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)
• Merge CT and D-SPECT image data to generate SUMO map.

Intervention Type: DEVICE

Ablation Procedure

1. CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO.

2. 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).

3. RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts)

4. Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA

5. Control HFS

6. At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.

7. Exit and entrance block confirmation

8. Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.

Intervention Type: PROCEDURE

D-SPECT

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

2. Male or female, age ≥ 50 years in the healthy volunteers group

3. No heart pathology (for volunteers)

4. PAF, Pers AF and L-s Pers AF (ECG documented).

5. LVEF ≥ 50%

6. Able to provide written informed consent

7. Able to comply with the requirements of the study

Exclusion Criteria

1. Previous AF ablation therapy

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

3. 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)

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

5. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spectrum Dynamics

INDUSTRY

Sponsor Role: collaborator

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

Role: CONTACT

abromanov@mail.ru

Facility Contacts

Evgeny Pokushalov, MD, PhD

Role: primary

E.Pokushalov@gmail.com

+79139254858

Other Identifiers

Volunteers+AF patients

Identifier Type: -

Identifier Source: org_study_id