Comparing simultaneous and sequential pacing methods for heart therapy
Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy
This study is testing whether pacing the heart at the same time or one after the other helps people with heart therapy feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT03301363 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the electrical changes in the heart when using simultaneous versus sequential left ventricular pacing during cardiac resynchronization therapy (CRT). It will involve a single-arm, non-randomized approach where patients scheduled for CRT will undergo assessments before discharge. Data will be collected through ECG and pressure-volume loop recordings under different pacing settings. The study is expected to last 12 months, with each participant's involvement spanning 1-2 days.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a QRS duration greater than 130 ms who meet the criteria for CRT according to ESC/EHRA guidelines.
Not a fit: Patients with recent myocardial infarction, NYHA Class IV heart failure, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize pacing strategies for patients undergoing cardiac resynchronization therapy, potentially improving their heart function.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in optimizing pacing strategies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA) * QRS duration \> 130 ms * Ability to provide informed consent for study participation * At least 18 years of age Exclusion Criteria: * Myocardial infarction within 40 days before enrolment * NYHA Class IV * Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction * Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries * VT with few or without clinically relevant symptoms * VT or VF treatable by surgery * Concomitant diseases that would substantially limit a positive prognosis * Accelerated intrinsic rhythm * Women who are pregnant
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico S. Donato — San Donato Milanese, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Pappone, MD — IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
- Study coordinator: Vincenzo Santinelli, MD
- Email: vincenzo.santinelli@gmail.com
- Phone: +39 0252774260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.