Heart Failure With Reduced Ejection Fraction Clinical Trial
— HISalternativeOfficial title:
Direct HIS-pacing as an Alternative to Biventricular Pacing in Symptomatic Heart Failure Patients With Severely Reduced LVEF and a True Left Bundle Branch Block
Verified date | July 2021 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study will randomize 50 symptomatic heart failure patients with severely reduced left ventricular ejection fraction (LVEF) and a true left bundle branch block to either direct HIS-pacing or biventricular pacing and follow them for at least six months. The outcome is how often it is possible to achieve HIS-pacing at implant and during follow-up and if HIS-pacing leads to differences in symptoms or measurable clinical parameters as compared to biventricular pacing.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 10, 2020 |
Est. primary completion date | November 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with ischaemic or non-ischaemic cardiomyopathy - LVEF = 35 % as assessed by echocardiography - New York Heart Association (NYHA) class II-IV despite optimal medical therapy - Either found eligible for cardiac resynchronization therapy (CRT-P or CRT-D) because of sinus rhythm and "true" LBBB according to Strauss criteria on a 12-lead ECG - or found eligible for upgrade of an existing pacing system to cardiac resynchronization therapy (CRT-P or CRT-D) because of sinus rhythm and "true" LBBB according to Strauss criteria on a 12-lead ECG or at least 90 % right ventricular pacing in the preceding two months. - Signed informed consent Exclusion Criteria: - Existing biventricular pacing system - Permanent atrial fibrillation - Severe kidney failure (eGFR < 30 ml/min) - Acute myocardial infarction or Coronary By-pass Grafting within the preceding three months - unwillingness to participate |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen | Hovedstaden |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Vinther M, Risum N, Svendsen JH, Møgelvang R, Philbert BT. A Randomized Trial of His Pacing Versus Biventricular Pacing in Symptomatic HF Patients With Left Bundle Branch Block (His-Alternative). JACC Clin Electrophysiol. 2021 Apr 25. pii: S2405-500X(21)0 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate of obtaining capture of HIS-bundle with narrowing of the QRS-duration | What is the success rate of implanting a pacing lead to the HIS bundle with narrowing of the QRS duration and maintaining this effect during the course of the study | 6 months | |
Secondary | Fall in end-systolic volume > 15% | How many HIS-paced patients as opposed to BiV paced patients have a fall in end-systolic volume > 15 % of the initial value? | 6 months |
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