Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

NCT00976482 | Completed Results DMC

• 1 other identifier: 07-09
• Study Type: observational
• Target: 1,745
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.

Conditions

Bradyarrhythmia

Keywords

Cardiovascular; Pacemaker; Mortality; Physiologic pacing

Outcome Measures

Primary Outcomes (1)

• Two-year All-cause Mortality

  2 years

Study Arms (1)

Pacemaker

Patients currently implanted with permanent Pacemaker according to guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient implanted with permanent pacemaker accroding to guidelines.

You may qualify if:

• Patients implanted with a current Boston Scientific pacemaker (all ALTRUA models) or any future commercially available Boston Scientific PM families according to international and local guidelines for pacemaker implantation;
• Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
• Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

You may not qualify if:

• Unable to be followed up by the participating centres for a period of two years;
• Current device implanted for more than 15 days;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
• Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. Each instance should be brought to the attention of the sponsor to determine eligibility.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Katholisches Krankenhaus, St.Johannes Hospital

Hagen, Germany

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: dr Mauro Biffi
• Organization: ospedale S Orsola- Malpighi, Bologna, Italy

mauro.biffi@aosp.bo.it

+393337661449

Study Officials

• Mauro Biffi, MD

  Az. Osp. S. orsola - Malpighi, Bologna, Italy

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 1, 2017
• Results First Posted: December 2, 2016

Record last verified: 2016-12

Locations

DE (1)