Bradycardia, Heart Block, Sick Sinus Syndrome
Conditions
Brief summary
This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.
Interventions
DEVICEInsignia Ultra and Insignia AVT
Regular AV-Delay increase to allow for intrinsic AV conduction, if present.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.
Exclusion criteria
* Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR \> 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Atrio-ventricular hysteresis algorithm on percentage of Ventricular pacing | At 12 Months | % Vp is compared between patients with atrio-ventricular hysteresis algorithm ON and OFF in patients with sino-atrial disease or paroxysmal AV block. |
Countries
France, Guadeloupe
Outcome results
None listed