Status:
COMPLETED
Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Swiss National Fund for Scientific Research
Conditions:
Cardiac Pacing, Artificial
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute he...
Detailed Description
By recruiting native conducting tissue to relay electrical activation of the ventricles via the Purkinje fibre network, DHBP may potentially achieve greater electrical resynchronization and hemodynami...
Eligibility Criteria
Inclusion
- Treatment of heart failure with a standard indication for CRT (NYHA III-IV, LVEF \< 35% and QRS \> 130ms; or LVEF\< 40% and requirement for frequent ventricular pacing, irrespective of baseline QRS duration) and optimal medical treatment.
- Permanent atrial fibrillation (allowing connection of the DHBP lead to the atrial port).
- Patients implanted with 1) a CRT pacemaker or CRT defibrillator 2) a His lead with selective or non-selective DHBP, connected to the atrial port of the generator 3) a functional right ventricular lead and 4) a functional coronary sinus lead.
- DHBP with selective or non-selective His capture
Exclusion
- Age \<18 years
- Pregnancy
- Inability to undergo CT or an MRI (e.g. due to severe claustrophobia)
- Inability or refusal to sign the patient informed consent form.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03452462
Start Date
April 1 2019
End Date
November 26 2020
Last Update
December 1 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Geneva
Geneva, Canton of Geneva, Switzerland, 1211