Trial Outcomes & Findings for Early Elimination of Premature Ventricular Contractions in Heart Failure (NCT NCT01757067)

Last Updated: 2021-03-18

Results Overview

Left ventricular ejection fraction with Simpson's Rule. This is a measurement obtained on an echocardiogram. It reflects the percentage of blood that is ejected from the heart with each beat. The mean change in ejection fraction will be compared for the 2 groups

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Change between 0 and 6 months

Results posted on

2021-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	PVC Ablation Plus Optimal Medical Therapy Patients will receive optimal medical therapy including beta blocker or afterload reduction with e.g. ACE-inhibitors as directed by treating local cardiologist/electrophysiologist. In addition patient will undergo radiofrequency ablation of PVC guided by current gold standard of ablation including pace mapping and activation mapping to reduce the PVC burden.	Optimal Medical Therapy Patients will receive optimal medical therapy including beta blocker or afterload reduction with e.g. ACE-inhibitors as directed by treating local cardiologist/electrophysiologist.
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Elimination of Premature Ventricular Contractions in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ablation Procedure n=2 Participants Patient received PVC ablation in addition to optimal medical therapy	Medical Therapy n=1 Participants Optimal medical therapy	Total n=3 Participants Total of all reporting groups
Age, Continuous	67 Years STANDARD_DEVIATION 3 • n=5 Participants	68 Years STANDARD_DEVIATION 0 • n=7 Participants	67 Years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment China	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change between 0 and 6 months

Population: Due to very low enrollment and closure of study no meaningful statistical analysis could be performed

Outcome measures

Outcome measures
Measure	Ablation Procedure n=2 Participants PVC ablation will be performed in these patients in addition to optimal medical therapy.	Optimal Medical Therapy n=1 Participants group received only optimal medical therapy
Change of Left Ventricular Ejection Fraction Measured With Simpson's Rule Expressed in Percent From Pre to Post Intervention	35 Percentage of EF Standard Deviation 5	30 Percentage of EF

Adverse Events

Ablation Procedure and Optimal Medical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Optimal Medical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Timm-Michael Dickfeld

University of Maryland Medical Center

Phone: 410-328-7801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place