Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NHS REC | Registry Identifier | 193216/878714/1/459 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart. Tablets to try to normalise the heart rhythm rarely work well. As a result, doctors have devised a treatment called catheter ablation in which special wires are used to deliver heat energy (called ablation lesions) on the inside surface of the heart. Unfortunately, in many patients (almost 1 in 2), some of these ablation lesions recover, and this leads to AF recurrence. Many of these patients then need a second procedure to deliver further ablation at these recovered areas.
Recent research has shown that monitoring of heat delivery with a factor called Ablation Index may be useful in predicting which ablation lesions are less likely to recover. Therefore, we aim to carry out AF ablation guided with Ablation Index (AI) and observe whether this will be associated with better durability of ablation lesions, and thereby better freedom from AF.
This study will include patients with persistent AF, those whose AF episode(s) last for longer than seven days. All patients participating in the study will undergo an initial ablation treatment guided by ablation Index . All patients will undergo a repeat procedure 8-10 weeks after their initial treatment. Any gaps found during the second procedure will be closed again by delivery of ablation.
All participants will be issued with a simple to use handheld heart rhythm monitor, and asked to make a 30-second recording of their heart rhythm each day and also whenever they have symptoms. The monitor stores these recordings and they will be downloaded at review appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation procedure.
The study is a prospective cohort study in 40 patients with Persistent AF. It will comprise two groups:
End-points
Primary outcome measure:
The proportion of patients with pulmonary vein (PV) reconnection seen at repeat EP study
Secondary outcome measures:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation Index Group | Active Comparator | PVI using radiofrequency ablation (RFA) guided by Ablation Index. |
|
| Reference Group (Contact Force Group) | Other | That group will be formed by the 40 patients who underwent mandatory repeat EPS 8-10 weeks following contact force guided PVI in the PRESSURE study (ClinicalTrials.gov Identifier: NCT01942408). RFA ablation data from reference group (Contact Force Group) will be compared with those obtained from the Ablation Index Group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI using ThermoCool® SmartTouch® Catheter | Device | PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with PV reconnection seen at repeat EP study | 8-10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of reconnected PVs seen at repeat EP study | 8-10 weeks | |
| The proportion of patients maintaining freedom from atrial fibrillation. | 12 months | |
| Quality of Life (QOL) using score of AFEQT Questionnaire. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dhiraj Gupta, MD, DM, FRCP | Liverpool Heart and Chest Hospital, Liverpool, UK | Study Chair |
| Ahmed A Hussein, MRCP, MSc | Liverpool Heart and Chest Hospital, Liverpool, UK | Principal Investigator |
| Moloy Das | Freeman Hospital, Newcastle, UK | Principal Investigator |
| Antonio D Russo | Centro Cardiologico Monzino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino, IRCCS, | Milan | 20138 | Italy | |||
| Liverpool Heart & Chest Hospital NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26108982 | Background | Das M, Wynn GJ, Morgan M, Lodge B, Waktare JE, Todd DM, Hall MC, Snowdon RL, Modi S, Gupta D. Recurrence of atrial tachyarrhythmia during the second month of the blanking period is associated with more extensive pulmonary vein reconnection at repeat electrophysiology study. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):846-52. doi: 10.1161/CIRCEP.115.003095. Epub 2015 Jun 24. | |
| 30354288 |
| Label | URL |
|---|---|
| The Effect of Early Repeat Atrial Fibrillation (AF) Ablation on AF Recurrence (PRESSURE) Study | View source |
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 27, 2018 | |
| Reset | Feb 21, 2019 | |
| Release | Feb 28, 2019 | |
| Reset | Jun 4, 2019 | |
| Release | Feb 19, 2020 | |
| Reset | Mar 2, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 27, 2018 | Feb 21, 2019 | |||
| Feb 28, 2019 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RFA ablation data comparison | Device | Ablation data from previous ablations, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), that members of this group had in the past, will be compared with those of the Active Comparator Group. |
|
AFEQT score will be obtained as the sum of units on the questionnaire's scale. |
| 6 and 12 months |
| QOL using score of EQ-5D-5L Questionnaire. | EQ-5D-5L score will be obtained as the sum of units on the questionnaire's scale. | 6 and 12 months |
| Major complications percent. | Occurring within 60 days after a PVI procedure. |
| Liverpool |
| L14 3PE |
| United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Derived |
| Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576. |
| Jun 4, 2019 |
| Feb 19, 2020 | Mar 2, 2020 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |