Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy. However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like. This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach. In this crossover trial, participants will be upgraded to a physiological pacing strategy. After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing). They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods. Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire. The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (\>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:

• EF reduced by \>5% of increase in LVESV by 10ml since implant

• NT-proBNP \>250ng/L in sinus rhythm

• NT-proBNP \> 750 Ng/L if AF

• Left atrial volume index \> 30ml/m2

• Regular loop diuretics prescribed

• Decline in daily patient activity by \>1 hour per day since implant

• Decrease in device measured thoracic impedance

• Patient reported decline in functional class or exercise tolerance

Locations
Other Locations
United Kingdom
Royal Papworth Hospital
RECRUITING
Cambridge
St. Richard's Hospital - University Hospitals Sussex
RECRUITING
Chichester
University Hospitals Coventry and Warwickshire NHS Trust,
RECRUITING
Coventry
Croydon University Hospital - Croydon Health Services
RECRUITING
Croydon
Glenfield Hospital
RECRUITING
Leicester
Hammersmith Hospital
RECRUITING
London
King's College Hospital
RECRUITING
London
St Bartholomew's Hospital - Barts Health NHS Trust
RECRUITING
London
Oxford University Hospitals
RECRUITING
Oxford
University Hospitals Southampton
RECRUITING
Southampton
Great Western Hospitals
RECRUITING
Swindon
Worthing Hospital - University Hospitals Sussex
RECRUITING
Worthing
Contact Information
Primary
Aya Khalil
a.khalil@imperial.ac.uk
07749576830
Backup
Nandita Kaza, MRCP
n.kaza@imperial.ac.uk
07749576830
Time Frame
Start Date: 2023-09-25
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 155
Treatments
Experimental: Physiological Pacing (Conduction System Pacing or Biventricular Pacing)
The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
Active_comparator: Right Ventricular Pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)
Related Therapeutic Areas
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov

Similar Clinical Trials