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This clinical trial evaluates the efficacy and safety of axillary versus cephalic venous access in the pacemakers and defibrillators implantation.
Half of participants will receive the implant via fluoroscopy guided axillary venous access and the other half will receive the implant via improved cephalic venous access.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXILLARY VEIN ACCESS | Active Comparator | This group of subjects will receive the implant of device via fluoroscopy-guided axillary puncture technique. |
|
| CEPHALIC VEIN ACCESS | Active Comparator | This group of subjects will receive the implant of device via optimized cephalic vein cutdown technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implant | Device | Implantation of endovenous cardiac stimulation device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Success | Success of the implant through the assigned access vein | 30 days |
| Implant Complications | All implant related complications | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lead Complications | Lead fracture or dysfunction | From date of implant until the date of first documented, assessed up to 48 months |
| Upper limb thrombosis | Thrombosis of the ipsilateral upper limb |
| Measure | Description | Time Frame |
|---|---|---|
| Time to access. | Time until reaching venous access. | From cutaneous incision to reach the right atrium with the guidewire, assessed up to 45 minutes. |
| Time of implant. | Intervention time. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Jiménez DÃaz, Dr. | Arrhythmia Unit Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Ciudad Real | Ciudad Real | 13005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11341082 | Background | Calkins H, Ramza BM, Brinker J, Atiga W, Donahue K, Nsah E, Taylor E, Halperin H, Lawrence JH, Tomaselli G, Berger RD. Prospective randomized comparison of the safety and effectiveness of placement of endocardial pacemaker and defibrillator leads using the extrathoracic subclavian vein guided by contrast venography versus the cephalic approach. Pacing Clin Electrophysiol. 2001 Apr;24(4 Pt 1):456-64. doi: 10.1046/j.1460-9592.2001.00456.x. | |
| 28064251 |
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All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
Anyone who wishes to access the data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 |
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| Defibrillator implant | Device | Implantation of endovenous cardiac defibrillation device. |
|
| AXILLARY VEIN ACCESS | Procedure | Fluoroscopy-guided axillary puncture to get vein access |
|
| CEPHALIC VEIN ACCESS | Procedure | Optimized cephalic vein cutdown to get vein access |
|
| From date of implant until the date of first documented, assessed up to 48 months |
| Pneumothorax | Implant related pneumothorax | 30 days |
| Bleeding | Implant related bleeding | 30 days |
| From the skin incision to the skin suture, assessed up to 180 minutes. |
| Background |
| Squara F, Tomi J, Scarlatti D, Theodore G, Moceri P, Ferrari E. Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access. Europace. 2017 Dec 1;19(12):2001-2006. doi: 10.1093/europace/euw363. |
| 31310038 | Derived | Jimenez-Diaz J, Higuera-Sobrino F, Piqueras-Flores J, Perez-Diaz P, Gonzalez-Marin MA. Fluoroscopy-guided axillary vein access vs cephalic vein access in pacemaker and defibrillator implantation: Randomized clinical trial of efficacy and safety. J Cardiovasc Electrophysiol. 2019 Sep;30(9):1588-1593. doi: 10.1111/jce.14060. Epub 2019 Jul 23. |
| Feb 25, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| ID | Term |
|---|---|
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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