Tachycardia-induced Cardiomyopathy Clinical Trial
Official title:
Role of the Wearable Cardioverter Defibrillator in Tachycardia Induced Cardiomyopathy. A Prospective Study
The purpose of this current study is to prospectively enroll consecutive patients hospitalized with newly diagnosed severe left ventricular dysfunction (LVEF ≤ 35%) for which the likely etiology is uncontrolled atrial fibrillation or high burden of ventricular ectopy. Patients completing their established in-hospital treatment plan with rate or rhythm control, will be discharged with a WCD following informed consent and detailed counseling by healthcare personnel for a time-period of up to 3 months until reassessment of LVEF and the need for ICD implantation.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with newly diagnosed left ventricular dysfunction (LVEF = 35% following cardioversion or rate stabilization) with either of the following: - Newly diagnosed atrial fibrillation - High burden of premature ventricular contractions (PVCs) (15% of total beats on 24-hour ambulatory Holter recording with a rapid ventricular response > 100 beats per minute prior to initiation of medical therapy) and no other likely heart failure (HF) etiology - Appropriate management during hospitalization with cardioversion and rhythm control (preferable) or rate control (if cardioversion is contraindicated due to a left atrial thrombus or is not successful) Exclusion Criteria: - HF likely due to an etiology other than tachyarrhythmia (ischemic etiology, myocarditis, hypertrophic or dilated cardiomyopathy, etc.) - Unstable clinical condition, life threatening arrhythmia or an established indication for ICD/CRT-D implantation during the index hospitalization - Patients with ICD/CRT-D or established (> 3 months) heart failure - Cognitive impairment or unable to utilize WCD appropriately - Patient has a chest circumference at the level of the xiphoid process either less than 26 inches or greater than 56 inches |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular recovery following WCD use. | Left ventricular recovery following WCD use. | 3 months | |
Secondary | Recurrence of atrial tachyarrhythmias | Recurrence of atrial tachyarrhythmias | 12 months | |
Secondary | Recurrence of ventricular tachyarrhythmias | Recurrence of ventricular tachyarrhythmias | 12 months | |
Secondary | Appropriate shocks by WCD | Occurrence of appropriate shocks as recorded by WCD (number of Shocks delivered during the follow up period) | 3 months | |
Secondary | Inappropriate shocks by WCD | Occurrence of Inappropriate shocks as recorded by WCD (number of Inappropriate Shocks delivered during the follow up period) | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05467163 -
Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation
|
N/A |