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Physiologic Pacing Registry
trial testing Physiologic pacing device implant in Bradycardia in 870 participants. Completed in 7 October 2021.
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 870 |
| Start date | 27 November 2018 |
| Primary completion | 7 October 2021 |
| Estimated completion | 7 October 2021 |
| Sites | 50 locations across France, Hong Kong, Italy, Netherlands, South Africa, India, Austria, Germany |
Abbott Medical Devices — full company profile →
18 and older, any sex, with Bradycardia or Sinus Node Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
849 subjects underwent attempted implants of physiologic pacing leads. Implant success rate was based on investigator-reported outcome.
| Group | Value | 95% CI |
|---|---|---|
| Physiologic Pacing Registry | 768 |
The pacing capture threshold was collected to characterize electrical performance in the Bundle of His area at 6 months. Pacing capture threshold is the minimum amount of voltage (V) needed to depolarize the myocardium or heart muscle with an electrical impulse from a pacemaker, ICD, or CRT.
| Group | Value | 95% CI |
|---|---|---|
| Physiologic Pacing Registry | 1.59 | ± 0.97 |
The pacing capture threshold was collected to characterize electrical performance in the Left Bundle Branch area at 6 months. Pacing capture threshold is the minimum amount of voltage (V) needed to depolarize the myocardium or heart muscle with an electrical impulse from a pacemaker, ICD, or CRT.
| Group | Value | 95% CI |
|---|---|---|
| Physiologic Pacing Registry | 0.79 | ± 0.33 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Physiologic Pacing Registry |
|---|---|---|
| Infection | Infections and infestations | — |
| Lead Migration/Dislodgement | Product Issues | — |
| Exacerbation Of Heart Failure | Cardiac disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Death | General disorders | — |
| Gastrointestinal Bleeding | Gastrointestinal disorders | — |
| Cardiac Tamponade | Injury, poisoning and procedural complications | — |
| Pneumothorax | Injury, poisoning and procedural complications | — |
| Rise In Threshold/Elevated Pacing Threshold | Product Issues | — |
| Hyperglycemia | Endocrine disorders | — |
| Decrease In General State Of Health | General disorders | — |
| Covid 19 Infection | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Atrial Extrasystole | Cardiac disorders | — |
| Cardiogenic Shock | Cardiac disorders | — |
| Coronary Artery Disease | Cardiac disorders | — |
| Nonsustained Ventricular Tachycardia | Cardiac disorders | — |
| Pleural Effusion | Cardiac disorders | — |
| Premature Atrial Complex | Cardiac disorders | — |
| Pulmonary Edema | Cardiac disorders | — |
| Rapid Atrial Flutter | Cardiac disorders | — |
| Unstable Angina | Cardiac disorders | — |
| Ventricular Fibrillation | Cardiac disorders | — |
| Intestinal Lesions | Gastrointestinal disorders | — |
| Reaction | System | Physiologic Pacing Registry |
|---|---|---|
| Lead Migration/Dislodgement | Product Issues | — |
| Rise In Threshold/Elevated Pacing Threshold | Product Issues | — |
| Loss Of Pacing And/Or Sensing | Product Issues | — |
| Infection | Infections and infestations | — |
| Dyspnea | General disorders | — |
| Hematoma/Seroma | Injury, poisoning and procedural complications | — |
| Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall) | Product Issues | — |
| Oversensing | Product Issues | — |
| Complete Heart Block | Cardiac disorders | — |
| Pacemaker-Mediated Tachycardia | Cardiac disorders | — |
| Palpitations | Cardiac disorders | — |
| Dizziness | General disorders | — |
| Left Upper Extremity Edema | General disorders | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Chest Pain | Injury, poisoning and procedural complications | — |
| Incision Site Dehiscence | Injury, poisoning and procedural complications | — |
| Lead Migration/Dislodgement | Injury, poisoning and procedural complications | — |
| Pneumothorax | Injury, poisoning and procedural complications | — |
| Swelling At Incision Site And Left Arm | Injury, poisoning and procedural complications | — |
| Thromboemboli | Injury, poisoning and procedural complications | — |
| Hematoma/Seroma | Investigations | — |
| Interruption Of Desired Pulse Generator Function Due To Electrical Interference | Product Issues | — |
| Lead Malfunction Due To Conductor Fracture/Lead Fracture | Product Issues | — |
| Undersensing | Product Issues | — |
| Left Upper Extremity Edema | Vascular disorders | — |
Most-reported serious reactions: Infection, Lead Migration/Dislodgement, Exacerbation Of Heart Failure, Atrial Fibrillation, Death, Gastrointestinal Bleeding, Cardiac Tamponade, Pneumothorax.
Data from ClinicalTrials.gov NCT03719040 adverse events section.
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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