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Recruitment too slow. Unrealistic to finish study with full inclusion cohort.
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Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium.
Patient population:
90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation.
Primary endpoint:
Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation.
Secondary endpoints:
Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conduction System pacing plus AV node ablation | Experimental | A His-pacing lead in combination with a backup RV pacing lead or an LBB pacing lead, and a right atrial lead (if needed) will be placed using standard technique. The His-pacing or LBB pacing lead will be Medtronic 3830, and the outer sheath will be either Medtronic C304 or C315 deflectable. If failure to implant with these tools, other leads and sheaths can be used at the discretion of the operator. A standard DDD pacemaker or CRT-P device from Medtronic will be used. A minimum of three weeks post-implant, the device will be interrogated and His-bundle threshold will be evaluated. A threshold of ≤2.0V@1.0ms is acceptable. If the device is well-functioning and successful His-pacing is documented, AV node ablation will be performed. |
|
| Pulmonary vein isolation | Active Comparator | Atrial fibrillation will be performed as a complete pulmonary vein isolation. Either Cryoballon or radio frequency ablation with irrigated tip contact force enabled catheter can be used. Pulsed field ablation can be used if available. Endpoint is complete electrical isolation of all pulmonary veins, verified by entry- and exit block using a multipolar catheter during pacing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction System pacing and AV node ablation | Procedure | See study arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health related Quality of Life: questionnaire | Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Proportion of patients with major adverse events | Proportion of patients with major adverse events that are devicerelated or related to ablation procedure (including but not limited to exit block, infection, perforation/tamponade, pericardial effusion, lead dislodgement, TIA/stroke, oesophago-atrial fistula, groin hematoma or vascular complication, pseudoaneurysm, phrenic nerve injury). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasmus Borgquist, MD PhD | Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University | Linköping | Sweden | ||||
| Skane University Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Patients are randomized to either
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| Atrial fibrillation ablation by pulmonary vein isolation | Procedure | See study arm description |
|
| 12 months |
| Mental Quality of Life: questionnaire | Improvement of the "mental" health related quality of life, measured by the mental component summary (MCS) of the SF-36 questionnaire | 12 months |
| Arrhythmia related Quality of Life: ASTA questionnaire | Change in arrhythmia related quality of life as measured by the The Arrhythmia-Specific questionnaire in Tachycardia. The ASTA questionnaire consists of 13 items, each with a score of 0-4. A higher score denotes more symptoms associated with the arrhythmia. and Arrhythmia (ASTA) questionnaire | 12 months |
| Anxiety and depression | Anxiety and depression symptoms, measured by the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 questions with 0 to 3 points for each, with a higher score denoting more depression/anxiety | 12 months |
| Ejection fraction | Change in left ventricular systolic ejection fraction | 12 months |
| Biomarker for heart failure | Change in NT-ProBNP level | 12 months |
| Physical performance | Change in six minute walk test distance | 12 months |
| Electrocardiography changes | Change in QRS duration on ECG | 12 months |
| Health economy | Total atrial fibrillation and device related health care cost | 12 months |
| Survival | Total survival and survival free of major complications | 3 years |
| Hospitalization for heart failure | Risk of hospitalization for heart failure assessed by Kaplan Meier time dependent analysis using time from ablation to first hospitalization for heart failure within three years | 3 years |
| Lund |
| 221 85 |
| Sweden |
| Stockholm Arrhythmia Center | Stockholm | Sweden |
| Varberg Hospital | Varberg | Sweden |
| D013568 |
| Pathological Conditions, Signs and Symptoms |