Complication Clinical Trial
— IMPACT IIOfficial title:
Improving Oesophageal Protection During AF Ablation: a Multicentre Double-blind Randomized Clinical Trial.
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the oesophagus caused by thermal energy being transmitted to the oesophagus from the heart. The oesophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe oesophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In a recent study, it was shown that a more advanced type of oesophageal probe that cools the oesophagus during ablation is better at protecting the oesophagus from ablation-related injury compared to the standard care probe currently used. As it was a single-centre study, more evidence is required before knowing if this type of probe is more effective in protecting the oesophagus. The purpose is to run a multi-centre randomized study to compare the safety of AF ablation when there is protection by the oesophageal cooling probe versus the standard of care oesophageal temperature monitoring probe. This means that there is a 50:50 chance of the new cooling probe being used during AF ablation for participants.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | March 10, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: • All AF patients deemed suitable for AF ablation treatment (under general anaesthetic) as per international guidelines and the patient has already decided on AF ablation treatment and are waiting for this procedure. Exclusion Criteria: - Inability to consent for any reason. - Inability to have the endoscopy follow up for any reason. - Those in extremities of age (<18 or >85) will not be recruited. - Those with a history of upper gastrointestinal tract bleeding or at risk of trauma e.g. esophageal varices or stricture which means there is a contraindication for instrumentation of the esophagus for any reason during the ablation. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Queen Elizabeth Hospital | Birmingham | |
United Kingdom | Guy's and St Thomas' NHS Foundation Trust | London | |
United Kingdom | St.George's Hospital | London | |
United Kingdom | Royal Brompton & Harefield NHS Foundation Trust | Uxbridge | |
United States | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | NCH Research Institute | Naples | Florida |
United States | Kansas City Cardiac Arrhythmia Research LLC | Overland Park | Kansas |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Advanced Cooling Therapy, Inc., d/b/a Attune Medical | Berry Consultants, Beth Israel Deaconess Medical Center, Guy's and St Thomas' NHS Foundation Trust, Kansas City Cardiac Arrhythmia Research LLC, National Health Service, United Kingdom, Royal Brompton & Harefield NHS Foundation Trust, St. George's Hospital, London, Texas Cardiac Arrhythmia Research Foundation, The Queen Elizabeth Hospital, University of Pennsylvania, Virginia Commonwealth University |
United States, United Kingdom,
Leung LW, Gallagher MM, Santangeli P, Tschabrunn C, Guerra JM, Campos B, Hayat J, Atem F, Mickelsen S, Kulstad E. Esophageal cooling for protection during left atrial ablation: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2020 Nov;59(2):347-355. doi: 10.1007/s10840-019-00661-5. Epub 2019 Nov 22. — View Citation
Leung LW, Gallagher MM. Esophageal cooling for protection: an innovative tool that improves the safety of atrial fibrillation ablation. Expert Rev Med Devices. 2020 Oct;17(10):981-982. doi: 10.1080/17434440.2020.1824674. Epub 2020 Sep 21. — View Citation
Leung LWM, Gallagher MM. Letter in reply to Gianni et al on "Prevention, diagnosis, and management of atrioesophageal fistula". Pacing Clin Electrophysiol. 2020 Nov;43(11):1417-1418. doi: 10.1111/pace.14012. Epub 2020 Sep 3. No abstract available. — View Citation
Zagrodzky J, Gallagher MM, Leung LWM, Sharkoski T, Santangeli P, Tschabrunn C, Guerra JM, Campos B, MacGregor J, Hayat J, Clark B, Mazur A, Feher M, Arnold M, Metzl M, Nazari J, Kulstad E. Cooling or Warming the Esophagus to Reduce Esophageal Injury During Left Atrial Ablation in the Treatment of Atrial Fibrillation. J Vis Exp. 2020 Mar 15;(157). doi: 10.3791/60733. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of endoscopically detected oesophageal thermal injury related to AF ablation. (Endoscopy at times 12-72 hours). | An upper gastrointestinal endoscopy diagnostic camera is performed under local anaesthetic spray and sedation. This is to screen for ablation-related thermal injury, which is highly characteristic and separate from other pathologies. This is performed for ALL participants of the trial regardless of randomization to study or control group. | Performed once, at 12-72 hours post ablation | |
Secondary | Procedure duration (minutes). | A measure for procedure efficiency | Measured once. At time of AF ablation procedure (day 0) | |
Secondary | Fluoroscopy duration (minutes) | A measure for procedure efficiency | Measured once. At time of AF ablation procedure (day 0) | |
Secondary | Incidence of major adverse events (MACCE) at times 0, 3, 6, 12 months. | A measure of safety of AF ablation across both randomized groups. | Measured 4 times, at times: 0, 3, 6, 12 months from time of ablation. | |
Secondary | Ability to attain procedural endpoints during AF ablation. | A measure of efficacy and efficiency of the AF ablation procedure:
Attainment of ablation targets, including isolation of all veins and production of proven bidirectional block across all lines attempted. Attainment of first-pass isolation for each set of veins Persistence of isolation through waiting period and adenosine test (if used at operator's discretion). |
Measured once at time points: time of AF ablation procedure (day 0). | |
Secondary | Incidence of clinically significant chest/gastroenterological symptoms post ablation | Incidence of severe gastroenterological symptoms, indicative of oesophageal reflux or gastroparesis, from validated questionnaires (gastro-esophageal reflux disease score (GERDQ) and gastroparesis cardinal symptoms index (GCSI) score) administered >3 months from time of ablation. | Measured once at time points: 3 months from AF ablation procedure | |
Secondary | Recurrence of treated atrial arrhythmia (AF or related AT) | Record any evidence of return of the treated arrhythmia at follow up cardiac monitoring: includes, 12 lead ECG, Holter, implantable loop recorders, non-invasive ECG monitors, mobile ECG apps. A return of AF (treated arrhythmia) must satisfy clear ECG/monitoring evidence of AF/related AT for >30 seconds. This is a measure of the success of the AF ablation procedure. | Measured at these time points: 3, 6, 12, 24 months from time of ablation procedure. |
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