Same-day implantation of heart failure pacemakers
One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers
Biotronik SE & Co. KG · NCT05142293
This study tests if putting in heart failure pacemakers on the same day can be safe and effective for patients, compared to those who need to stay in the hospital overnight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 436 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotronik SE & Co. KG (industry) |
| Locations | 22 sites (Bayonne and 21 other locations) |
| Trial ID | NCT05142293 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of same-day cardiac resynchronization therapy pacemaker (CRT-P) implantations in selected French centers. It compares outcomes of patients undergoing same-day procedures with those who are routinely hospitalized for at least one night. The study aims to demonstrate significant cost savings and a low conversion rate to full hospitalization. A medical economic evaluation will be conducted using data from the National Health Data System.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for a de novo CRT-P implantation or upgrade who can provide informed consent and are enrolled in the heart failure registry.
Not a fit: Patients in emergency situations, those with prior implantable cardiac defibrillators, or those requiring specific types of pacing systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more efficient and cost-effective treatment for heart failure patients requiring CRT-P implantation.
How similar studies have performed: Similar studies have shown promising results in the feasibility of outpatient procedures, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned de novo implantation or upgrade to a Cardiac Resynchronization Therapy Pacemaker system according to the intended use * Patient is able to understand the nature of the registry and has provided written informed consent for BIO\|STREAM.HF (heart failure registry) and the registry-based trial BIO\|OEDIPE.CRT-P * Patient enrolled in BIO\|STREAM.HF (heart failure registry) Exclusion Criteria: * Patients in emergency situation or without medical assessment before hospitalisation for implantation * Patients previously implanted with an implantable cardiac defibrillator system * Patients with an implantable cardiac defibrillator indication * Patients planned to be implanted with an epicardial left ventricular lead (not implanted via the coronary sinus) * Patients planned to be implanted with His bundle pacing system
Where this trial is running
Bayonne and 21 other locations
- GCS Centre de Cardiologie du Pays Basque — Bayonne, France (RECRUITING)
- CHU Brest — Brest, France (RECRUITING)
- CHU Caen — Caen, France (RECRUITING)
- Hôpital Louis Pasteur — Chartres, France (TERMINATED)
- CHU Dupuytren — Limoges, France (WITHDRAWN)
- Hôpital Saint Philibert — Lomme, France (TERMINATED)
- CH Bretagne Sud — Lorient, France (TERMINATED)
- CHU La Timone — Marseille, France (TERMINATED)
- Hôpital Privé Jacques Cartier — Massy, France (RECRUITING)
- Clinique Les Fontaines — Melun, France (RECRUITING)
- CHU Montpellier — Montpellier, France (RECRUITING)
- Clinique du Millénaire — Montpellier, France (TERMINATED)
- Hôpital Privé du Confluent — Nantes, France (RECRUITING)
- Hôpital La Pitié-Salpêtrière — Paris, France (RECRUITING)
- CHU Haut Lévèque — Pessac, France (WITHDRAWN)
- CH Saint Lô — Saint-Lô, France (RECRUITING)
- CHU Saint Etienne — Saint-Étienne, France (RECRUITING)
- Nouvel Hôpital Civil — Strasbourg, France (RECRUITING)
- CHU Toulouse — Toulouse, France (WITHDRAWN)
- Clinique Pasteur — Toulouse, France (TERMINATED)
- CHRU de Tours - Hôpital Trousseau — Tours, France (RECRUITING)
- CH Valence — Valence, France (RECRUITING)
Study contacts
- Principal investigator: Jean-Luc Pasquié, Prof. — University Hospital, Montpellier
- Study coordinator: Amandine Wouters
- Email: bio-oedipe@biotronik.com
- Phone: +33(0)146759660
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.
Conditions: Heart Failure