Trial Outcomes & Findings for Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study (NCT NCT00246805)

NCT ID: NCT00246805

Last Updated: 2011-09-28

Results Overview

Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 67 participants
• Primary outcome timeframe: June 2009
• Results posted on: 2011-09-28

Participant Flow

enrollment period: from january 2006 till november 2008

Participant milestones

Measure	VRS ON Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)	VRS OFF Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
Phase 1 STARTED	34	33
Phase 1 COMPLETED	33	33
Phase 1 NOT COMPLETED	1	0
Phase 2 STARTED	33	33
Phase 2 COMPLETED	33	33
Phase 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	VRS ON Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)	VRS OFF Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
Phase 1 Lost to Follow-up	1	0

Baseline Characteristics

Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study

Baseline characteristics by cohort

Measure	VRS ON n=34 Participants Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)	VRS OFF n=33 Participants Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Age Continuous	80 years STANDARD_DEVIATION 6 • n=5 Participants	80 years STANDARD_DEVIATION 6 • n=7 Participants	80 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment Italy	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: June 2009

Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.

Outcome measures

Measure	VRS ON n=66 Participants Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)	VRS OFF n=66 Participants Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) No Preference	19 participants	19 participants
Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) Preference VRS ON	32 participants	32 participants
Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) Preference VRS OFF	15 participants	15 participants

SECONDARY outcome

Timeframe: January 2009

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: January 2009

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: January 2009

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: January 2009

Outcome measures

Outcome data not reported

Adverse Events

VRS ON

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

VRS OFF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	VRS ON n=34 participants at risk Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)	VRS OFF n=33 participants at risk Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
Infections and infestations HOSPITALIZATION	2.9% 1/34 • Number of events 1	0.00% 0/33
Cardiac disorders HOSPITALIZATION FOR HF	2.9% 1/34 • Number of events 1	0.00% 0/33

Other adverse events

Adverse event data not reported

Additional Information

Giorgio Corbucci - Sr Principal Scientist

Medtronic BRC - Medtronic Italia

Phone: +39 02 241371

Email: giovanna.zucchi@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee should INVESTIGATOR contemplate publishing/presenting, he shall provide copies of any abstracts, papers, or manuscripts to sponsor for review at least 30 days prior to submittal for publication or presentation. Sponsor shall limit its review to a determination of whether Confidential Information is disclosed and to check for technical correctness and shall not attempt to censor or in any way interfere with PARTICIPATING INSTITUTION's or INVESTIGATOR's presentation or conclusions
• Publication restrictions are in place

Restriction type: OTHER