An interventional study of EVIA Pacemaker in Pacemaker Indication, sponsored by Biotronik SE & Co. KG. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2011-10-07.
Sponsored by Biotronik SE & Co. KG · Not applicable, Interventional, and Treatment
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: EVIA Pacemaker
patient has standard indication for pacemaker therapy
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually.
Time frame: 1 month follow-up completed
Complication Free Rate
Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients)
Time frame: 1- and 3- month follow-up completed
In this study the data of n = 175 patients from 34 clinical sites in Austria, Denmark, France, Germany, Spain, Sweden and United Kingdom are included. The period of investigation covered was between June 04, 2009 (day of first implant) and February 26, 2010 (day of last follow-up).
| Milestone | Pacemaker Therapy |
|---|---|
| Started | 175 |
| Completed | 167 |
| Not completed | 8 |
| Withdrew: Death | 2 |
| Withdrew: Icd upgrade | 1 |
| Withdrew: Drop-out | 5 |
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually.
| Volt | Pacemaker Therapy |
|---|---|
| Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) | -0.01 (-0.03 to 0.02) |
Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients)
| Percentage complication free patients | Pacemaker Therapy |
|---|---|
| Complication Free Rate | 99 (96 to 100) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pacemaker Therapy | — | 52/175 (29.7%) | 28/175 (16%) |
| Event | Pacemaker Therapy |
|---|---|
| lead dislocationSurgical and medical procedures | 10/175 |
| cardiac decompensationCardiac disorders | 5/175 |
| pocket haematomaSkin and subcutaneous tissue disorders | 4/175 |
| spinal diseaseNervous system disorders | 4/175 |
| Atrial fibrillation / flutter relatedCardiac disorders | 3/175 |
| chest painCardiac disorders | 3/175 |
| coronary angiographySurgical and medical procedures | 3/175 |
| intestinal diseaseGastrointestinal disorders | 3/175 |
| lung related hospitalisationRespiratory, thoracic and mediastinal disorders | 3/175 |
| pacemaker/ICD exchange/repositioningSurgical and medical procedures | 3/175 |
| Event | Pacemaker Therapy |
|---|---|
| OthersGeneral disorders | 11/175 |
| pacemaker relatedCardiac disorders | 10/175 |
| gastrointestinal diseaseGastrointestinal disorders | 3/175 |
| circulation problemsCardiac disorders | 2/175 |
| lead dislocationSurgical and medical procedures | 2/175 |
| Age Continuous(years) | Pacemaker Therapy |
|---|---|
| Mean | 74 ± 10.5 |
| Age, Customized(participants) | Pacemaker Therapy |
|---|---|
| Between 34 and 93 years | 175 |
| Sex: Female, Male(Participants) | Pacemaker Therapy |
|---|---|
| Female | 83 |
| Male | 92 |
| Region of Enrollment(participants) | Pacemaker Therapy |
|---|---|
| Austria | 32 |
| Denmark | 19 |
| France | 9 |
| Germany | 93 |
| Spain | 16 |
| Sweden | 4 |
| United Kingdom | 2 |
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Biotronik SE & Co. KG